Text Size

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
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
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

No publications provided by Medical University of Vienna

Additional 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
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013