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

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00149409

First received: September 6, 2005

Last updated: July 12, 2010

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

July 12, 2010

Start Date ^ICMJE

September 2005

Primary Completion Date

February 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00149409 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Heart Failure

Intervention ^ICMJE

Dietary Supplement: Omacor

Study Arms

Placebo Comparator: Placebo
4 gelatine capsules/d

Intervention: Dietary Supplement: Omacor
Active Comparator: 1g/d Omacor
Intervention: Dietary Supplement: Omacor
Active Comparator: 4g/d Omacor
Intervention: Dietary Supplement: Omacor

Publications *

Moertl D, Hammer A, Steiner S, Hutuleac R, Vonbank K, Berger R. Dose-dependent effects of omega-3-polyunsaturated fatty acids on systolic left ventricular function, endothelial function, and markers of inflammation in chronic heart failure of nonischemic origin: a double-blind, placebo-controlled, 3-arm study. Am Heart J. 2011 May;161(5):915.e1-9. doi: 10.1016/j.ahj.2011.02.011.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

February 2008

Primary Completion Date

February 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00149409

Other Study ID Numbers ^ICMJE

n3-PUFA-HF

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rudolf Berger, MD

Medical University of Vienna

PRS Account

Medical University of Vienna

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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