LION-Heart and LAICA clinical trials: differences and similarities
Advanced heart failure (AdHF) is associated with high morbidity and mortality, and imposes considerable burdens on the health systems of developed countries. The LION-HEART and LAICA trials are part of a suite of clinical studies of intermittent levosimendan therapy in this setting.
The LION-HEART trial evaluated the safety and efficacy of repetitive 6-hourly doses of levosimendan (0.2 μg/kg/min) every 2 weeks, as compared to placebo. The primary endpoint is the change in NT-proBNP levels from baseline to 12 weeks, in a population of 70 adult patients with left ventricular ejection fraction <35% and diagnostic criteria of advanced chronic heart failure.
The LAICA study assessed the effects of intermittent levosimendan (0.1 μg/kg/min every 30 days for 1 year) on combined overall mortality rate and hospital admission rate for acute cardiac decompensation or HF worsening, in 213 adults with AdHF of any aetiology, including at least one admission for acute decompensation within 6 months prior to randomisation. Sub-studies were planned to examine effects on renal function and the cost-effectiveness of levosimendan.
Both these Phase IV trials, conducted in Spain, are double-blind and placebo-controlled. LION-HEART has a smaller patient population but is powered for its primary focus on NT-proBNP levels, which are indicative of heart failure status. The larger LAICA trial emphasises widely-accepted and established clinical and health-related quality of life outcomes. The results were presented in Seville (ESC-HF 2015) and Florence (ESC-HF 2016), respectively, and provide insights into the usefulness, effectiveness and safety of intermittent levosimendan as an addition to the pharmacological repertoire for advanced heart failure.
Professor Gerhard Pölzl highlights Hospitalisation for the management of acute decompensation being a critical moment in the trajectory of heart failure (HF) and one that has gloomy prognostic implications for many patients.
There have been some recent achievements in the LEODOR trial including a new website to facilitate administration and communication and submission of a formal study protocol synopsis to the European Journal of Heart Failure.
If we had a way to reduce the risk of life-threatening complications after cardiac surgery would we use it? Of course we would. It is for reason that this blog post highlights the recent work of Dr. Qiang and colleagues. See the details here.
Professor Gerhard Pölzl reports primary results from the LION-HEART study in the management of advanced heart failure where among secondary endpoints, patients treated with levosimendan experienced a reduction in the rate of HF-related hospitalisation compared with placebo.
Professor Cynthia M Dougherty and colleagues outline an array of options for the treatment of advanced heart failure (HF) that create – quite reasonably – the impression that we are in a golden age of therapeutic possibilities for this difficult condition.