ELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE
Status:
Terminated
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare in patients with Advanced Chronic Heart Failure the
effects of Levosimendan versus diuretic (single 24-hour infusion) applied at the early
detection of impending destabilization on hospitalization-free survival during 12 months.
Patients with advanced chronic heart failure (ACHF) have a short term reduced life expectancy
with recurrent hospital admissions for clinical exacerbations. Levosimendan improves
contractility by calcium-dependent binding to troponin C, determines vasodilation of the
coronary arteries and systemic resistance vessels, thus decreasing preload and afterload,
while exerting a protective effect on the myocardium against ischemia-reperfusion damage. In
randomized clinical trials of acute heart failure patients, levosimendan improved
hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels,
with no excess mortality The study will assess whether the administration of levosimendan
(single 24-hour infusion) at the early detection of deterioration may reduce frequency and
duration of hospital admissions, improve functional status and quality of life in ACHF
patients, with respect to diuretic infusion.