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Clinical trial

Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure (LAICA)

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Last updated:1st Nov 2009
Identifier: NCT00988806
Study Type:
Interventional 
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title:
Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of Intermittent, Long-term Administration of Levosimendan in Patients With Advanced Heart Failure
 
Resource links provided by NLM:
 
MedlinePlus related topics: Heart Failure 
U.S. FDA Resources 
 
Further study details as provided by Martín J García González, Hospital Universitario de Canarias:
 
Primary Outcome Measures: 
Evaluate the incidence of admission for heart failure worsening in patients with advanced heart failure, defined as first admission to emergency services or hospitalization more than 12 hours due to a heart failure worsening. [ Time Frame: one year ]
 
Secondary Outcome Measures: 
Time from randomization until first hospitalization for heart failure worsening. All-cause mortality. Major cardiac events. Serious adverse events. Changes in NYHA scale and quality of life of patients. To analyze the cost-effectiveness of treatment. [ Time Frame: one year ]
 
 
Estimated Enrollment:
213
Study Start Date:
November 2009
Estimated Study Completion Date:
December 2014
Estimated Primary Completion Date:
December 2013 (Final data collection date for primary outcome measure)
Category Value
Date last updated at source 2013-09-18
Study type(s) Interventional
Expected enrolment 213
Study start date 2009-11-01
Estimated primary completion date 2013-12-01

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