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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

September 6, 2005
July 12, 2010
September 2005
February 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00149409 on ClinicalTrials.gov Archive Site
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Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
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
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
Dietary Supplement: Omacor
  • 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
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.
 
Completed
Not Provided
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00149409
n3-PUFA-HF
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Medical University of Vienna
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Principal Investigator: Rudolf Berger, MD Medical University of Vienna
Medical University of Vienna
September 2005

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