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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
  Purpose
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

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

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: September 6, 2005
Last Updated: July 12, 2010
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016