Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure

Medical University of Vienna

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Heart Failure

Treatments: Dietary Supplement: Omacor

Study type: Interventional

Funder types: Other

Identifiers

NCT00149409

n3-PUFA-HF

Details and patient eligibility

About

To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

4 gelatine capsules/d

Treatment:

Dietary Supplement: Omacor

1g/d Omacor

Active Comparator group

Treatment:

Dietary Supplement: Omacor

4g/d Omacor

Active Comparator group

Treatment:

Dietary Supplement: Omacor