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

This study has been completed.
Information provided by:
Medical University of Vienna Identifier:
First received: September 6, 2005
Last updated: July 12, 2010
Last verified: September 2005
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.

Condition Intervention Phase
Chronic Heart Failure Dietary Supplement: Omacor Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
4 gelatine capsules/d
Dietary Supplement: Omacor
Active Comparator: 1g/d Omacor Dietary Supplement: Omacor
Active Comparator: 4g/d Omacor Dietary Supplement: Omacor


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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Please refer to this study by its identifier: NCT00149409

Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Rudolf Berger, MD Medical University of Vienna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00149409     History of Changes
Other Study ID Numbers: n3-PUFA-HF
Study First Received: September 6, 2005
Last Updated: July 12, 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 22, 2017