Peroral Levosimendan in Chronic Heart Failure

Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study

The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.

The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Inclusion Criteria:

• Diagnosed chronic heart failure
• Severe symptoms (NYHA IIIb-IV)
• Optimal on-going oral treatment for HF
• Left ventricular ejection fraction less than or equal to 30%

Exclusion Criteria:

• Severe obstruction of ventricular outflow tracts
• Acute myocardial infarction within 30 days before screening
• Cardiac surgery or coronary angioplasty within 30 days before screening