Peroral Levosimendan in Chronic Heart Failure
Phase 2
Completed
- Conditions
- Chronic Heart FailureHeart Diseases
- Registration Number
- NCT00130884
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
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.
- Detailed Description
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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%
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite endpoint measuring symptoms, morbidity, mortality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Helsinki University Central Hospital
🇫🇮Helsinki, Finland