Effect of Levosimendan or Placebo on Exercise in Advanced Chronic Heart Failure

• Status: Unknown status
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.

Hypothesis: Treatment with 6 hours infusion of levosimendan compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP.

Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. 42 consecutive patients who meet the eligibility criteria will be enrolled.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finn Gustafsson
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

Inclusion Criteria:

• Age ≥18 years

• NYHA III-IV on optimal medical treatment

• LVEF ≤35%

• NT-proBNP >600 µg/L

• pVO2 <20 mL/kg/min

• No hospitalization for HF or change in loop diuretic <2 weeks

Exclusion Criteria:

• Recent or acute coronary and respiratory syndromes

• Recent sustained ventricular tachycardia or ventricular fibrillation

• Severe aortic or mitral valve disease

• Known malfunctioning artificial heart valve

• Uncorrected obstructive valvular disease

• Hypertrophic cardiomyopathy

• Fertile women

• Uncorrected thyroid disease

• Presence of any disease/condition that might per se influence exercise performance

• Left ventricular assist device

• Pacemaker-guided heart rate at rest or during exercise

• Known contraindication for treatment with levosimendan

• Any treatment with levosimendan in the previous 6 months

• Inability to perform a VO2max test

• Symptomatic hypotension or systolic blood pressure < 90 mmHg