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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149409
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : July 13, 2010
Sponsor:
Information provided by:
Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Dietary Supplement: Omacor Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : September 2005
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149409


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149409     History of Changes
Other Study ID Numbers: n3-PUFA-HF
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: July 13, 2010
Last Verified: September 2005

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases