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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

4 gelatine capsules/d

Group Type PLACEBO_COMPARATOR

Omacor

Intervention Type DIETARY_SUPPLEMENT

1g/d Omacor

Group Type ACTIVE_COMPARATOR

Omacor

Intervention Type DIETARY_SUPPLEMENT

4g/d Omacor

Group Type ACTIVE_COMPARATOR

Omacor

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omacor

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No