ELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Niguarda Hospital
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Diuretics; Simendan

Criteria

Inclusion Criteria:

• Written informed consent

• Systolic dysfunction (LVEF ≤ 35% by echo assessment within 6 months before enrolment)

• No requirement for hospital admission for diagnostic work up or elective treatment to define etiology and/or treatment plan

• Already on optimal standard HF treatment based on individual tolerance, including cardiac resynchronization therapy (CRT)/ICD device according to current guidelines

• At least 2 hospital admissions for HF in the 6 months before enrolment, the most recent one within 30-90 days before enrolment with requirement for inotrope administration

Exclusion Criteria:

• Participant in other studies in the last 30 days

• Life expectancy < 1 year for comorbid conditions other than HF

• Pregnancy, lactation, childbearing potential unless on adequate contraception

• Acute coronary syndromes, percutaneous or surgical revascularization, valve surgery performed within 8 weeks before enrolment

• Planned percutaneous or surgical procedures (except for heart transplantation)

• CRT within 6 months before enrolment

• Cardiogenic shock

• Supine systolic BP < 85 mmHg

• Severe liver insufficiency (>three-fold increase in AST-ALT )

• Sever chronic kidney dysfunction (estimated GFR < 30 ml/min)

• Sustained ventricular tachycardia

• Severe chronic or current acute infection (temperature >38 C, WBC >15,000/mm3)

• Severe chronic obstructive pulmonary disease (FEV1 <30% predicted or on oxygen therapy)

• Severe persistent anemia (Hb < 10 g/l))

• ACHF exacerbation due to conditions requiring specific treatment (e.g. anemia, atrial fibrillation, supraventricular tachycardia ) Documented low compliance or unavailable for programmed follow-up visits and phone contact