Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
Phase 2
Completed
- Conditions
- Chronic Heart Failure
- Interventions
- Dietary Supplement: Omacor
- Registration Number
- NCT00149409
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Chronic heart failure of non-ischemic origin
- Age ≥18 years
- NYHA functional class III-IV
- LVEF < 35 %
- Optimized heart failure therapy
- plasma NT-BNP >2000pg/ml
Exclusion Criteria
- Current treatment with Omacor or other fish oil products
- Known hypersensitivity to the study drug
- Ischemic cardiomyopathy
- Uncorrected significant valvular heart disease
- Heart failure due to congenital heart disease
- Restrictive cardiomyopathy
- Alcoholic heart disease
- Acute myocarditis
- Continuous i.v. therapy for heart failure
- Mechanical assist device
- Life expectancy <1 year due to non-cardiac causes
- Inability to perform bicycle testing
- Women of childbearing potential not practicing a save contraception method
- Current participation in another intervention study
- Participation in another study with an intervention within the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Omacor 4 gelatine capsules/d 1g/d Omacor Omacor - 4g/d Omacor Omacor -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria