Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed TomographyApr 2013
The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In this prospective study the investigators validate DE-CT results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. The investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in PregnancyApr 2013
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.
CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD SubjectsApr 2013
The study is designed to evaluate how safe and how well an investigational imaging product CardioPET™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.
Atrial Fibrillation (AF) and Physical Exercise (EXAF)Mar 2013
To explore the role of alternative treatment strategies and to renew handling of cardiac arrhythmia, we have therefore set out to study the role of physical exercise in AF patients. Our specific study aims are to examine: - The effect of physical exercise on AF burden - The effect of physical exercise on the risk of cardiovascular hospitalization
A Pilot Study of a Novel Technique for Cardiac Resynchronisation Therapy to Treat Heart Failure (LV-CONSEPT)Mar 2013
Cardiac resynchronisation therapy (CRT) is known to result in significant improvement in the symptoms of selected patients with heart failure, and to reduce hospital admission and death rates in these patients. CRT can improve cardiac function by improving the coordination of the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of the veins running around the outside of the heart, to stimulate the outside of the left ventricle (main pumping chamber). There are two particular issues with this standard technique. In some patients it is not possible to get the wire into the coronary sinus due to difficult vein shapes, and in others the wire can be put there, but it does not end up in a suitable position to act on the heart enough to improve heart function. This is thought to be a major part of the reasons why one in four patients does not improve with CRT ("non-responders"). The investigators have developed a novel method of pacing the left ventricle of the heart by putting the wire through a tiny hole made in the muscle between the left and right ventricles and pacing the inside surface of the left ventricular chamber. This will allow patients in whom the coronary sinus cannot be used to have CRT. The investigators will also offer it to patients who have not improved with CRT, as there is evidence that they may respond to this procedure due to physiological benefits from pacing the inside rather than the outside and also the ability to steer the lead anywhere on the inner surface. The investigators have performed this new procedure in a small number of patients already. This study will allow closer follow-up of more patients, and also investigation of ways to optimize results of the procedure for these patients.
The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)Mar 2013
The purpose of this study is to the assess the clinical performance of the BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) TrialMar 2013
This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.
Effects of oral chronic administration of ivabradine (7.5 mg bid) in comparison to placebo (bid) on top of beta-blockers, on central aortic blood pressure. Randomized, cross-over, double blind, multicentre, study over 10 weeks in patients with stable coronary artery disease, type II diabetes and a resting heart rate equal or superior to 70 bpm, already treated with beta-blockers.Mar 2013
To evaluate the effect of ivabradine on central aortic systolic blood pressure (CASBP) in comparison to placebo in patients with stable CAD, type II diabetes, and a resting HR≥ 70 bpm, treated by beta-blockers.
Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients (CHOLESS)Mar 2013
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)Mar 2013
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication (SAFARI)Mar 2013
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AFMar 2013
The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF recurrences within 6 months after electrical cardioversion in patients with persistent AF.
Non-invasive and Invasive Assessment of Coronary Artery Disease (COMFORT)Mar 2013
The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.
Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With CancerFeb 2013
The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.
A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor AutoantibodiesFeb 2013
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.
Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure (TAME-HF)Feb 2013
The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).
A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)Feb 2013
This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male participants with mild-to-moderate hypertension (Panel C).
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)Feb 2013
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
Ultrasound by Nurses in Heart Failure PatientsFeb 2013
Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent ImplantationFeb 2013
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.
Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, international, multicentre study.Feb 2013
To assess the effect of ivabradine compared to placebo on the diastolic function, the exercise capacity and the neuroendocrine activation over an 8-month treatment period.
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)Feb 2013
The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on fifty (50) eligible patients with a twelve month follow-up period.
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential HypertensionFeb 2013
This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.
Mainz Registry of Flow-mediated ConstrictionFeb 2013
The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the measurement of endothelial function using flow-mediated dilation and flow-mediated constriction provides on the presence of coronary atherosclerosis and on the prognosis of patients undergoing coronary angiography.
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)Feb 2013
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant recipients: a randomized double blinded placebo controlled intervention study.Feb 2013
To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n-3 polyunsatturated fatty acids compared to placebo.
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)Feb 2013
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii)Feb 2013
The study objectives are to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. Secondly, to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life.
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart FailureJan 2013
The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.
Study on the Clinical Course Of Pulmonary Embolism (SCOPE)Jan 2013
The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown. Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient. Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims: - to ascertain the actual incidence of symptomatic CTEPH after a first episode of acute PE; - to ascertain the actual incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE; - to evaluate whether a relation exists between chronic residual PE and CTEPH - to evaluate whether a relation exists between chronic residual PE and VTE recurrences; - to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH; - to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences. For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.
Validation of Myocardial Perfusion Imaging (CameraCZT)Jan 2013
The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.
Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)Jan 2013
The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.
Atrial Fibrillation/Sinus Rhythm Before and After CardioversionJan 2013
This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.
Early Care After Discharge of HF Patients (ECAD-HF)Jan 2013
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome. This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.
Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.Jan 2013
The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. Ultimately this may lead to an increase the number of hearts available for transplantation.
Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)Jan 2013
The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)Jan 2013
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems (MATRIX)Jan 2013
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.
A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects with Heart Failure and Left Ventricular Systolic DysfunctionJan 2013
The aim of this study is to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects with HF and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) after 12 weeks of treatment.
The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques (PREDICT)Jan 2013
The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques. Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction. Prediction of changes in coronary arteries based on changes in non-invasive examinations. Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.
Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects with Moderate to Severe Essential HypertensionJan 2013
The primary objective is to evaluate the long-term safety and tolerability of FDC of nifedipine GITS / candesartan cilexetil (primarily the highest dose) once daily in subjects with moderate to severe essential hypertension.
The Efficacy and Safety of Valsartan and Combination of Valsartan and Hydrochlorothiazide in the Treatment of Patients with mild to moderate Arterial Hypertension.Jan 2013
The aim of the study is to establish the efficacy and safety of Valsacor (valsartan) and Valsacombi (combination of valsartan and hydrochlorothiazide) in wide populations of patients with mild to moderate arterial hypertension.
Study to Investigate the Effect of Heart Rate Reduction With Ivabradine on Vascular Elastic Properties and Endothelial Function in Patients With Stable Coronary Heart DiseaseJan 2013
This study investigates whether chronic heart rate reduction with ivabradine (Procoralan®, Servier, France) affects aortic compliance and endothelial function in patients with chronic stable coronary artery disease.
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment (STARLIGHT)Jan 2013
The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.
Renal Denervation in Treatment Resistant Hypertension (ReSET-2)Jan 2013
The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.
Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH)Jan 2013
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.
ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable StentJan 2013
This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.
Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart FailureDec 2012
To test if infusion of the V1A/V2-receptor blocker conivaptan improves hemodynamics and physical capacity in HF patients on optimal HF medical therapy and to improve understanding of the role of vasopressin in HF.
Dantrolene in catecholaminiergic polymorphic ventricular tachycardiaDec 2012
The aim of this trial is to assess the antiarrhythmic effects of dantrolene
Thiazide diuretics versus calcium channel blockers for the treatment of tacrolimus-induced hypertension after kidney transplantation: a single-center randomized cross-over trial.Nov 2012
To compare the blood pressure lowering effect of thiazides against calcium channel blockers in stable kidney transplant recipients with hypertension who are treated with CNIs.
Funen's strategy in the prevention of Blood clots in critically ill patients with acute kidney InjuryOct 2012
To reduce the incidence of venous thromboembolism(VTE) among patients on continuous renal replacement therapy (CRRT) by using 1 mg/kg enoxaparin, versus the standard dose of 40 mg enoxaparin.
Pharmacokinetics of Levosimendan in children with acute heart failureOct 2012
To describe the pharmacokinetic profile of levosimendan in children
An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee ArthroplastyOct 2012
• To assess the safety and efficacy profile of ISIS 416858, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty • To assess a potential dose-response relationship of ISIS 416858 with respect to the reduction of VTE incidence in patients undergoing total knee arthroplasty
Effect of fingolimod on cardiac autonomic regulation in MS-patientsOct 2012
To evaluate whether fingolimod has an effect on the heart rate variability or myocardial ventricular repolarisation in patients with multiple sclerosis?
Efficacy and safety of fixed-dose combination Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg versus Perindopril 5 mg / Indapamide 1.25 mg single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril 5 mg / Indapamide 1.25 mg single pill with conditional titration based on blood pressure control up to Perindopril 10 mg/ Indapamide 2.5 mg / Amlodipine 10 mg. An international, multicentre, randomised, double blind, 12-weeks superiority study.Oct 2012
To demonstrate the superiority effect of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus bi-therapy in single pill in lowering office systolic blood pressure at the end of one month of treatment.
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart FailureOct 2012
Determine the efficacy of a single intracoronary infusion of 1 x 10e13 DRP MYDICAR® added to an optimal HF regimen in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of heart failure (HF) by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients
Randomized, double-blind, placebo-controlled trial to compare the effect, three months of follow-on pulse pressure and vascular function of isosorbide mononitrate extended release, associated with antihypertensive treatment in patients over 65 years refractory isolated systolic hypertensionSep 2012
To compare the effect on clinic pulse pressure of extended release isosorbide mononitrate vs placebo, added to the usual treatment of patients over 65 with refractory ISH, after 3 months of treatment.
Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering from Acute Decompensated Heart Failure [TRUE-AHF]Sep 2012
To evaluate the effect of a continuous intravenous (IV) ularitide infusion on the clinical status of patients with ADHF.
A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Openlabel Titration PhaseSep 2012
To evaluate if a dose dependent reduction in MSBP exists when comparing two doses of valsartan solution over a 6wk period in children 1-5 years old with hypertension with or without CKD.
30 day, open-label, active-controlled, randomized study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosisSep 2012
The primary objective is to assess the incidence of major bleeding and clinically relevant non-major bleeding
Randomized, Double-Blind, Placebo-Controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart FailureAug 2012
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve LV-EF in patients with CHF and iron deficiency as determined by cardiac MRI.
Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction. A 6 to 12-month randomised double blind parallel groups multicentre study.Aug 2012
To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period
Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre studyAug 2012
To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period
Evolution of serologic biomarkers and diastolic function and segmentary contractility determined by echocardiography after treatment in Chagas diseasesAug 2012
Chagas disease (CD), caused by Trypanosoma cruzi, is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
A Phase III, International, Multi-Center, Randomised, Double-Blind, Placebo-Controlled, Event Driven Study to compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension receiving UT-15C in Combination with a PDE5-I or ERA compared with a PDE5-I or ERA AloneAug 2012
To assess the effect of oral UT-15C with ERA or PDE5-I therapy compared to placebo with ERA or PDE5-I therapy on time to first clinical worsening event, as defined by at least one of the events: Death (all causes),Hospitalization due to worsening PAH, Initiation of an inhaled or infused prostacyclin for the treatment of worsening PAH, Disease progression (all criteria required), Unsatisfactory long-term clinical response(all criteria required). To assess effect of UT-15C combined with oral ERA or PDE5-I therapy compared with placebo combined with oral ERA or PDE5-I therapy on the change in Baseline 6MWD measured at Week 24
An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310Aug 2012
The primary objective of this study is to provide UT-15C sustained release tablets for eligible subjects who participated in TDE-PH-310 (A phase III, International multi-center, randomised, double-blind, placebo-controlled, event-driven study to compare the time to first clinical worsening in subjects with PAH receiving UT-15C in combination with a PDE5-I or ERA compared with a PDE5-I or ERA alone).
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects with Inadequately Controlled Hypertension + Pharmacogenetics Blood Sample Protocol Amendment 01- version 2.0, dated 05-Apr-2012Jul 2012
The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.
An open label, three-period, single sequence study to evaluate the pharmacokinetic drug-drug interaction between LCZ696 and sildenafil in subjects with mild to moderate hypertensionJul 2012
To investigate the effect of LCZ696 on single dose pharmacokinetics of sildenafil in subjects with mild To moderate hypertension. To investigate the effect of sildenafil on the steady-state pharmacokinetics of the LCZ696 analytes in subjects with mild To moderate Hypertension
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular EventsJul 2012
The primary objective is to demonstrate that no excess risk of CV composite events exists following treatment with TAK-875 compared with placebo when given in combination with Standard of Care in subjects with T2DM and clinically evident CV disease or multiple risk factors for CV events. For purposes of this study, the primary MACE composite comprises CV death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
Dabigatran and rivaroxaban: prediction of anticoagulant effectJun 2012
The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation. In addition, we want to investigate whether there is a correlation between the in-vivo effect and ex- vivo effect in a patient by spiking blood of patients before treatment with rivaroxaban or the active metabolite of dabigatran.
Sympathetic renal denervation versus increment of pharmacological treatment in resistant arterial hypertensionJun 2012
To determine the effect of a percutaneous catheter-based renal sympathetic denervation (RSD) procedure to disrupt renal afferent and efferent nerves using radiofrequency ablation, on 24h ambulatory systolic blood pressure (SBP), in subjects with resistant hypertension (RH), as compared to the addition of spironolactone, an aldosterone receptor blocker, to the baseline pharmacological treatment, from baseline (Visit 0) to Final Examination (Week 24).
Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)Jun 2012
To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy (XALIA)May 2012
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer ResectionMay 2012
This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.
A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINAMay 2012
After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA)
Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at High-risk for Recurrence of Venous ThromboembolismMay 2012
The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients
Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer PatientsMay 2012
Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.
A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial HypertensionMay 2012
To investigate the safety of continuous treatment with sc lisuride infusions as add-on treatment to stable conventional therapy in patients with pulmonary arterial hypertension (PAH).
A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients with Paroxysmal Atrial FibrillationMay 2012
To evaluate whether treatment with ISIS 329993 can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF as derived from continuous pacemaker monitoring) in subjects with paroxysmal AF.
The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients with Chronic Heart FailureMay 2012
The primary outcome is Peak VO2O2 consumption/workload relation during submaximal exercise.
Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill PatientsMay 2012
Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness
Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot TrialMay 2012
Patients with reduced kidney function (kidney disease) have high rates of hardening of the blood vessels, which leads to early heart disease and strokes. Previous research has shown that using low dosage of a 'water tablet', spironolactone in patients with early kidney disease in a hospital outpatient setting improved heart structure and function as well as reduced blood vessel stiffness. STOP-CKD study aims to determine if blood vessel stiffness can be safely reduced with the use of low dose spironolactine in people with early stage kidney disease managed at general practices.
A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of Aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin monotherapy.May 2012
To evaluate if aleglitazar improves cardiac energetics, by means of MRS, in uncomplicated T2D patients with no history of CAD, after 6 weeks of treatment
Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill PatientsMay 2012
Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness
A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertensionMay 2012
To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).
A Single Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after TransplantationApr 2012
To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.
Palliative Care in Heart Failure (PAL-HF)Apr 2012
The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.
Effect of Ranolazine in Heart Failure Patients with Preserved Ejection FractionApr 2012
The primary objective is to demonstrate that ranolazine treatment results in a placebo corrected improvement in the 6-minute walk test (6MWT) after 28 weeks of treatment
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)Apr 2012
The primary hypothesis of the CABANA trial is that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art medical therapy with either rate control or rhythm control drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest (key secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy. It is anticipated that treatment with percutaneous left atrial catheter ablation will reduce mortality with ≥ 30% compared to drug therapy. All endpoints will be carefully assessed and analyzed on an intention to treat basis.
Effects of clopidogrel vs prasugel vs ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patients undergoing coronary artery stenting. A randomised, prospective study.Apr 2012
The primary objective of the trial is to investigate the impact of the three treatments under study on endothelial function as assessed by flowmediated dilation (FMD) in patients who have undergone stenting.
Hellenic Anglo Research into Morning Or Night antihypertensive drug deliverY trial.Mar 2012
To detect if there is a 3mm Hg difference in average 24 hour systolic blood pressure when blood pressure lowering medications are taken in the evening compared with same medications taken in the morning.
Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial.Mar 2012
To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.
Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart FailureMar 2012
Patients with chronic heart failure need a "safe and effective" exercise program that will improve their quality of life. For this study, we will determine if adult chronic heart failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle Training (IMT) program will have an additional effect on respiratory muscle strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate variability, and physical activity level compared to subjects who are assigned to the home walking and "sham" Inspiratory Muscle Training (IMT) program.
Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous ThromboembolismMar 2012
The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.
A Prospective, Randomized, Double-Blind, Parallel-Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with Essential HypertensionMar 2012
To assess the therapeutic equivalence of eprosartan (a new formulation containing only the active moiety eprosartan) with eprosartan mesylate (currently marketed formulation) on sitting diastolic blood pressure (DBP) in ambulatory subjects with mild to moderate essential hypertension after 8 weeks of treatment (monotherapy).
Perindopril Amlodipine for the Treatment of Hypertension (PATH)Mar 2012
The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension
Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.Mar 2012
To assess the effects of Ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia
Studies of the effects of a one week course of either azithromycin or metronidazole on plasma concentration of procalcitonin in patients with heart failure and elevated plasma procalcitonin concentrationsFeb 2012
In patients with heart failure who have an elevated concentration of procalcitonin (a marker of infection) which is not explained by clinical evidence of infection, can treatment for one week with azithromycin or with metronidazole reduce plasma concentrations of procalcitonin compared to a control group who receive no antibiotics. Procalcitonin is associated with a poor prognosis so understanding the mechanism for an elevated concentration in those without infection may provide a therapeutic target.
Renal Denervation in Patients With Advanced Heart FailureFeb 2012
Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.
A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial HypertensionFeb 2012
The primary objective of this study is to evaluate the safety and tolerability of a rapid dose titration regimen of SC (subcutaneous) Remodulin therapy in patients with PAH. Safety and tolerability of the rapid dose titration regimen will be considered to be demonstrated by all clinical trial subjects that complete the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.
A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients with an Implantable Cardioverter DefibrillatorJan 2012
The primary objective of this study is to assess the impact of 75 mg azimilide versus placebo on the occurrence of unplanned (non-elective) cardiovascular hospitalizations, unplanned cardiovascular emergency department visits, or cardiovascular death in patients with an ICD. Analysis of efficacy will be done by comparing the effect of azimilide versus placebo on the time-to-first-occurrence of a qualifying event.
Remote Monitoring of Chronic Heart Failure in Veneto RegionJan 2012
The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.
Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive DisordersJan 2012
The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation. The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetesJan 2012
The main objective of the trial is to investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)
Superficial vein thrombosis (SVT) treated for forty-five days with Rivaroxaban versus FondaparinuxDec 2011
Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment
A phase 2, proof of concept, randomised, placebo-controlled, parallel group study to evaluate the effect of ranolazine and dronedarone when given alone and in combination on atrial fibrillation burden in subjects with paroxysmal atrial fibrillationDec 2011
To evaluate the effect of ranolazine and of low dose dronedarone when given alone and in combination at different dose levels on AFB over 12 weeks of treatment. AFB is defined as the total time a subject is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects with a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention with Incomplete RevascularizationDec 2011
The primary objective of this study is to evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.
Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric studyDec 2011
To compare the effect of renal sympathetic denervation with the spironolactone in treatment-resistant hypertension on blood pressure
Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory studyDec 2011
Evaluation of the effects on the occurrence of cardiac arrhythmia during standardized exercise tests (ETs)
An 8-week randomized, open label, multi-center study to study to evaluate the efficacy and safety of oral aliskiren 300 mg once daily under light meal versus fasted condition in patients with hypertensionDec 2011
To evaluate the efficacy of oral aliskiren 300 mg given once daily in reduction of mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of 8 week treatment under light meal (fed) versus fasted conditions in patients with mild to moderate hypertension.
A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial HypertensionNov 2011
Main objective of the trial is to characterize the pharmacokinetics (PK) of tadalafil in a pediatric population with pulmonary arterial hypertension (PAH) to establish an appropriate dose range for further clinical research.
Gulf Acute Heart Failure Registry (GulfCARE)Nov 2011
The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up. Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (IDENTIFY-HF)Nov 2011
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure with preserved ejection fraction (ejection fraction > 40%) will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose with Placebo in Patients with Chronic Heart Failure and Iron DeficiencyNov 2011
To determine, relative to placebo, the effect of iron repletion therapy using intrravenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation of therapy in subjects with CHF and ID
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery (DARINA)Sep 2011
The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneous administered nadroparin by observing the incidence of major bleeding and clinical relevant non-major bleeding in patients after knee arthroplasty surgery.
Effects of beta-blockers on exercise performance in uncomplicated hypertensionSep 2011
Evaluation of peak VO2, maximal exercise capacity and tollerance in hypertensive patients with 2 treatments versus vasodilator drugs of routine treatment (ACE inhibitors, sartans, Calcium-antagonists, doxazosina).
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism TreatmentSep 2011
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).
Vernakalant Versus Ibutilide In Recent-Onset Atrial FibrillationJun 2011
To compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.
Dopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situationJun 2011
The main objective of this trial is to compare dopamine versus no dopamine on top of standard treatment in patients with exacerbation of severe heart failure (NYHA class III-IV) in home situation. This study will investigate whether 24 hour dopamine infusion reduces the need of hospital admission for patients with exacerbation heart failure
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) (ROCITP2)May 2011
This multicentre, prospective cohort study aims to test the following hypotheses: - Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort) - Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal SurgeryMar 2011
The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endorcris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.
What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?Feb 2011
To assess the clinical value of using intravenous iron (ferric carboxymaltose) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension. The primary endpoint will be the change in the resistance to blood flow through the lungs (resting pulmonary vascular resistance), measured by cardiac catheterisation at baseline and 12 weeks after the initial infusion.
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft SurgeryFeb 2011
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients. The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide SystemJan 2011
his purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.
PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial PilotJan 2011
The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial with a placebo control to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.
Efficacy and safety of Canrenone Add on in patients with Essential HypertensionDec 2010
To asses the efficacy in the decrease of office DBP of Canrenone (Luvion), an aldosterone antagonist in addition to a antihypertensive therapy with ACE-inhibitor/ARB + diuretic
Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?Dec 2010
Reduction of left ventricular mass by reducing dietary phosphate intake with sevelamer carbonate.
Measuring Adherence to Control Hypertension (MATCH)Dec 2010
The purpose of this study is to test whether accurately measuring patients' adherence to their blood pressure medications with electronic pillbox monitors and then providing clinicians with this information can improve the clinical management of uncontrolled hypertension.
Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolismNov 2010
To determine whether Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two years after the initial 3-12 months of oral anticoagulant therapy in patients with unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) venous thromboembolism
The antitthrombotic effects of doxazosin and ramipril in essential hypertensionSep 2010
Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension?
Betablocker Therapy in Pulmonary Arterial HypertensionAug 2010
The main question of this study is: ‘Is selective beta-blocker treatment safe and effective in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients with iPAH?‘ Safety of Bisoprolol treatment in iPAH patients is not taken as a primary endpoint but seen as a precondition for this study and will be closely monitored. Dose titration will be guided by possible side effects. Furthermore, although beta-blocker are considered contraindicated in PAH patients, a considerable number of patients frequently receives beta-blocker therapy in an uncontrolled way (3), without any side effects being reported until now.
A randomised controlled trial of extended warfarin treatment versus routine warfarin treatment for the prevention of recurrent venous thromboembolism and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTEAug 2010
The overarching objective of this study is to improve the prevention and treatment of recurrent VTE and post-thrombotic syndrome in patients being treated for a first episode of a proximal (above the knee) unprovoked blood clot.
Virtual Hypertension Clinic (VHC)Jul 2010
This is a prospective, randomized controlled trial designed to determine whether blue tooth and telephone technology can be utilized to successfully relaying home blood pressure information electronically to healthcare providers so that timely and more frequent treatment interventions can be instituted to optimize and reach goal blood pressure level for an individual as compared to usual care.
An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgeryJun 2010
To assess the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot® and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery.
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INTMay 2010
The primary objective of the study is to assess the efficacy of Innohep® in preventing the recurrence of Venous Thromboembolism(VTE) in patients with active cancer who have had an acute Venous Thromboembolism (VTE) episode.
Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolismApr 2010
The primary objective of this study is to investigate pharmacokinetics and pharmacodynamics of single oral doses of rivaroxaban in paediatric subjects in order to obtain weight adjusted doses with equivalent exposure compared to 10 mg and 20 mg doses in adults.
A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AFApr 2010
The primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedarone.
Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.Apr 2010
This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE.
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)Mar 2010
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
Study to Evaluate the Effect of Zemplar on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 YearsFeb 2010
Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (Paricalcitol I.V.)
Multicentric, controlled, randomized phase IV clinical trial to evaluate clinical efficacy and safety of three different dosing schedules of furosemide in patients with moderate to severe descompensation of congestive heart failureFeb 2010
Comparar la diuresis a las 24 horas tras la administración de furosemida a 10 mg/h en infusión continua intravenosa, furosemida 20 mg/6 h en bolo intravenoso y furosemida 20 mg/8h en bolo intravenoso.
ACT-HF: Attention, Cognition and Self-Management in Heart FailureFeb 2010
This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.
Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Ischemic Heart Failure: a randomized placebo controlled trail.Dec 2009
We intend to assess the efficacy of cardiac stem cell therapy in ischemic heart failure patients. Specifically, we want to answer the question whether injection of autologous mononuclear bone marrow cells (BMCs) into the myocardium of no-option patients with ischemic heart failure leads to an improvement in Quality of Life, exercise capacity, myocardial perfusion and myocardial function.
EUropean Pharmacogenetics of AntiCoagulation Therapy trialDec 2009
The primary endpoint is the percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy. Our hypothesis is that pharmacogenetic guided dosing will increse the time within INR range if compared to non-pharmacogenetic guided dosing.
Simvastatin in Patients With Isolated Arterial Hypertension (STIPPARE)Nov 2009
The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.
A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolismNov 2009
Reduction of the risk of symptomatic recurrent venous thromboembolic complications in patients with acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin KOct 2009
Warfarin inhibits the activation of clotting factors by inhibiting the regeneration of vitamin K in the vitamin K cycle. Patients anticoagulated with warfarin are very sensitive to intake of vitamin K. We have demonstrated that daily supplementation with 150 µg vitamin K of patients with unstable control significantly increased the time they spent in their therapeutic anticoagulation range. We hypothesise that daily supplementation with vitamin K would reduce bleeding and thromboembolism in the anticoagulated population and, as a pilot investigation to a multicentre study to assess this, aim to measure the impact of vitamin K on stability of control in an unselected anticoagulated cohort.
Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure (LAICA)Sep 2009
The purpose of this study is to determine whether the treatment strategy of long-term intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan, associated to optimal contemporary treatment for advanced heart failure reduce the incidence of admission for heart failure worsening at 12 months follow up, compared with the strategy based solely in the optimal contemporary treatment for advanced heart failure
Effect of xantina oxidasi inhibition on left ventricular function and on energetic stores of the haert in patients affected by chronic cardiac insufficiency.Sep 2009
The main objective of this trial is to evaluete the netabolic effect of allopurinolo in patients with cardiac insufficiency and incremented uric acid values.
Long-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label studyAug 2009
To evaluate whether low-molecular-weight heparin (Enoxaparin, Dalteparine, Nadroparine, Tinzaparine) is superior to vitamin K antagonists (VKA) in the long-term treatment of symptomatic venous thromboembolism in cancer patients who have completed 6 to 12 months of anticoagulant treatment
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer PatientsAug 2009
The goal of this clinical research study is to learn if dalteparin can lower the risk of venous thromboembolism (VTE) occurring in the legs and lungs.
Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure.Jul 2009
To evaluate safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c ≥ 6% or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure (Proof of Concept).
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients with Heart Failure and Renal InsufficiencyJun 2009
The primary objective of this study is to assess the safety and tolerability of Tonapofylline administered to subjects with heart failure and renal insufficiency
Aspirin for the Prevention of Recurrent Venous ThromboembolismMay 2009
To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism
Venous Thromboembolism in Pregnancy Study (VIP)Mar 2009
The purpose of this study is to investigate clinical, biochemical and genetic risk factors for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the long-term outcome of such complications including implications for quality of life.
An investigation of the association between vitamin K intake, vitamin K epoxide reductase subunit (VKORC1) genotype and anticoagulation response to warfarinFeb 2009
Our principal research objective is to assess this by exploring the inter−relationships between stability of anticoagulation control, dietary vitamin K intake and VKORC1 genotype. Vitamin K is necessary for the activation of clotting proteins normally needed to stop us from bleeding. Warfarin causes anticoagulation (blood−thinning) by inhibiting the vitamin K epoxide reductase (VKOR) enzyme responsible for the recycling of vitamin K in the liver. VKOR enzyme production is controlled by the vitamin K epoxide reductase gene (termed VKORC1). Some individuals can have mutations of the VKORC1 gene. These individuals produce VKOR enzyme with reduced activity. Vitamin K in the diet works in a directly opposite way to warfarin, counteracting the anticoagulation(blood thinning) response to warfarin. There are theoretical reasons, and a small amount of evidence to support that the antagonistic effect of dietary vitamin K might not be the same between patients with different genotypes.
Cognitive Impairment in Patients With Heart Failure (CogImpairHF)Feb 2009
The aim of the present study is threefold: investigating 1) specific cognitive impairments in patients with congestive heart failure, 2) whether cognitive impairments in patients with decompensated heart failure improve after medical recompensation and 3) whether cognitive functioning is related to the long-term prognosis (mortality, rehospitalisation) of those patients.
Dalteparin Sodium Injection (Fragmin®), Multicenter, Open Label, Single-arm, Long Term (52 weeks) Study for Understanding Safety and Efficacy in Subjects with Malignancies and Symptomatic Venous ThromboembolismDec 2008
The primary objective of the study is to determine the rate of major bleeing events in cancer patients receiving extended treatment with dalteparin ( more than 6 months and up to 12 months) for prevention of recurrent symptomatic venous thromboembolism (VTE).
Predicting Bleeding Risk on Anticoagulant Therapy for Venous ThromboembolismNov 2008
The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.
A safety and efficacy trial evaluating the use of apixaban for the extended treatment of deep vein thrombosis and pulmonary embolism (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY- EXTended treatment. The AMPLIFY-EXT study)Jun 2008
To determine if at least one of the apixaban dose regimens is superior to placebo in the combined endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death in subjects who have an objectively documented index event of symptomatic proximal DVT or symptomatic PE, have completed approximately 6 to 12 months of anticoagulant therapy for the treatment of the index event, and have no objectively documented symptomatic recurrence of VTE after the index event.
A Multinational, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery.Jun 2008
The primary objective of the study is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of 20 mg AVE5026 (10 mg in SRI patients) with q.d. s.c. injections of 40 mg enoxaparin (20 mg in SRI patients) administered during 7-10 days after surgery for the prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip replacement surgery.
Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study.May 2008
To document the absence of retinal toxicity of ivabradine versus placebo in chronic stable angina patients after treatment cessation in the subset of patients with emergent bilateral relevant ERG abnormalities observed under treatment at M36.
ADOPT: Apixaban Dosing to Optimize Protection from Thrombosis. A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.Mar 2008
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a minimum period of 6 days, in subjects with acute medical illness.
RE-NOVATE II: a phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty.Feb 2008
The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery.
The Einstein-Extension study. Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.Feb 2008
The primary efficacy objective is to evaluate whether rivaroxaban is superior to placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 14 months of treatment with vitamin K antagonist (VKA) outside of the Einstein VTE treatment program (study 11702) or who completed 6 or 12 months with VKA or rivaroxaban in the 11702 study.
Adolescent Type 1 Diabetes Cardio-Renal Intervention TrialJan 2008
To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD)
Pharmacogenomics in Pulmonary Arterial HypertensionJan 2008
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity. Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as development/severity of PAH via their effect on PA remodeling, drug response, or metabolism. This study requires a one time 8.5 ml blood sample and clinical data to be obtained at initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of therapy.
A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.Sep 2007
The primary objective of this study is to determine whether aliskiren, when added to conventional treatment, compared to placebo, delays the occurrence of cardiovascular and /or renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events.
The effect of beta-adrenergic receptor blockade on sympathetic activity and coagulation in patients with heart failure (BACH-F study)Aug 2007
To analyse whether the hypercoagulable response to sympathetic activation in heart failure patients is reduced more effectively by carvedilol than metoprolol and whether this response differs from that in healthy controls. To analyse whether the hypercoagulable response to sympathetic activation in heart failure patients and in healthy controls is determined by the beta2-adrenergic genotype.
Telemonitoring in Patients With Heart Failure (TEHAF2)Jul 2007
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
Does statin therapy reduce sympathoexcitation in hypertensionJun 2007
The objective of the study is to assess the effect of atorvastatin on sympathetic activity in hypertension patients
The effect of Pioglitazone on vascular and ventricular function in people with type 2 diabetes PICCOLAMay 2007
This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.
A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential HypertensionMay 2007
To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiSBP) after 4 weeks of treatment with losartan/HCTZ combination therapy in comparison with losartan monotherapy in pediatric patients (defined as children aged 6-17 years who have the ability to swallow tablets) with essential hypertension (defined as patients ≥ the 95th percentile for SBP or DBP for gender/age/height) who are not adequately controlled following a 6-week single-blind losartan treatment (filter) period.
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.May 2007
For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) for the prevention of recurrent venous thromboembolic events. For the Einstein-PE evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic PE with or without symptomatic DVT for the prevention of recurrent venous thromboembolic events.
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive PatientsMar 2007
Evaluate the effect of telmisartan on inflammatory parameters in patients with hypertension.
Long-term, open-label, multicenter extension study of bosentan in patients with pulmonary hypertension associated with sickle cell disease completing a double-blind ASSET study (AC-052-368 or AC-052-369)Jan 2007
To assess long-term safety, tolerability and efficacy of bosentan in patients with pulmonary hypertension (PH) associated with sickle cell disease (SCD)
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography TestingDec 2006
The purpose of this study is to determine whether outpatient therapeutic management guided by impedance cardiography (ICG), in addition to standard clinical assessment, will result in a longer time in days to the first heart failure hospitalization than therapy guided by clinical assessment alone.
Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney DiseaseOct 2006
The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.
Perhexiline therapy in patients with heart failure with preserved left ventricular ejection fraction(HFpEF syndrome)Sep 2006
To test whether perhexiline improve exercise capacity (peak vo2) in patients with heart failure with preserved left ventricular ejection fraction(HFpEFsyndrome)
A phase IIb, randomized, parallel group, double blind, double-dummy, multi-center, multi national, multi-dose study of DU-176B compared to dalteparin in patients undergoing elective unilateral total hip replacementAug 2006
The primary objective of this study is to assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE).
NOSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs.Jul 2006
This study aims to assess efficacy and safety of testing for thrombophilia in patients with a first episode of VTE and subsequent additional anticoagulant treatment in those in whom thrombophilia is detected as compared to no testing and standard duration of therapy in all patients.
RE-MEDY, a phase III, randomised, multicenter, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism.May 2006
To determine the comparative efficacy of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic venous thromboembolism.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia.Apr 2006
To determine the efficacy of darbepoetin alfa compared with placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia.