Peroral Levosimendan in Chronic Heart Failure

Orion Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure; Heart Diseases

Treatments: Drug: levosimendan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130884

3001081

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind