NCT00149409CompletedPhase 2
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure:Effects On Endothelial Function, Left Ventricular Remodelling, Natriuretic Peptide Levels, And Exercise Capacity
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Locations
- 1
Study Overview
Brief Summary
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
4 gelatine capsules/d
Intervention: Omacor (Dietary Supplement)
1g/d Omacor
Active Comparator
Intervention: Omacor (Dietary Supplement)
4g/d Omacor
Active Comparator
Intervention: Omacor (Dietary Supplement)
Investigators
Study Sites (1)
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