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The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure

This study is currently recruiting participants.
Verified November 2012 by Columbia University
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ulrich Peter Jorde, Columbia University
ClinicalTrials.gov Identifier:
NCT00944229
First received: February 12, 2009
Last updated: November 18, 2012
Last verified: November 2012
History of Changes
  Purpose

A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this potential benefit is not well understood.

Methods:

Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4 gm a day) and 20 patients will receive placebo. All subjects will have assessment of their exercise capacity and blood vessel function before and after an 8 week treatment period. About 4 table spoons of blood will be drawn throughout the study.

Expected results:

The investigators believe that omega 3 may improve the ability to exercise and improve blood vessel function.


Condition Intervention Phase
Heart Failure
 Drug: LOVAZA (Omega-3)
Drug: Placebo
 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: Salutary Effects of Dietary Supplementation With OMEGA 3 on Exercise Performance and Endothelial Function in Patients With Congestive Heart Failure. A Matter of Lipid Oxidation ?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Changes in peak VO2 [ Time Frame: 0, 1 and 8 weeks of Omega 3 supplementation. ] [ Designated as safety issue: No ]
  • Change in reactive hyperemia peripheral arterial tonometry (RH-PAT) after 8 weeks of Omega 3 supplementation. [ Time Frame: 0 and after 8 weeks of Omega 3 supplementation. ] [ Designated as safety issue: No ]
  • Changes in base line oxidized low density lipoprotein (LDL) level and in response to exercise [ Time Frame: 0, 1 and 8 weeks of Omega 3 supplementation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug Treatment - LOVAZA
Drug Treatment - LOVAZA 4 gm q24 for 8 weeks
 Drug: LOVAZA (Omega-3)
LOVAZA 4 gm q24 for 8 weeks Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
Placebo Comparator: 2 placebo
Placebo 4 capsules q24 for 8 weeks
 Drug: Placebo
4 capsules of placebo every 24 hours

Detailed Description:

A diet rich in Omega-3 polyunsaturated fatty acids Omega 3 reduces plasma triglycerides and the risk for ischemic heart disease1, and may exert direct antiarrhythmic effect on the myocardium 2-9. A post-hoc analysis of the GISSI-Prevenzione trial demonstrated a reduction in all-cause and sudden mortality in a subgroup of nearly 2000 post-infarction patients with left ventricular dysfunction 10. This provocative finding has now been prospectively studied in a large-scale, randomized, double-blind study designed to investigate the effects of Omega 3 on mortality and morbidity in patients with symptomatic heart failure (the GISSI Heart Failure project). The results of the GISSI-HF trial demonstrate that 1 g per day of Omega 3 is associated with 9% reduction in mortality and cardiovascular admissions in patients with predominantly systolic heart failure, when added to optimal medical therapy11.

The mechanism(s) underlying these beneficial effects remains to be elucidated and will be critical in fully exhausting the therapeutic benefits of Omega 3 in CHF. We have recently demonstrated that lipid oxidation during acute exercise is altered in patients with CHF 12 and that the degree of this alteration carries prognostic significance. It is conceivable that Omega 3 modulates lipid oxidation during exercise and thereby favorably effect outcome. Accordingly we propose to study the effect of Omega 3 on lipid oxidation during exercise in CHF. We will further examine VO2 and endothelial function at present the principal surrogate markers for survival in CHF 13.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All subjects with CHF due to systolic dysfunction followed at the outpatient facilities of Columbia University Medical Center will be screened and subjects will be asked to participate if the following criteria are met:

  • Older than 18 years.
  • Symptomatic heart failure (New York Heart Association functional class II-III).
  • Ischemic or non-ischemic cardiomyopathy.
  • Left ventricular ejection fraction (EF) 40% or lower.
  • Peak oxygen uptake (VO2, peak) between 10 and 17 mL O2/min/kg.
  • Be on appropriate, stable medical treatments for heart failure, including (unless shown to be intolerant) a diuretic, an angiotensin-converting enzyme inhibitor and/or angiotensin-receptor blocker and a beta-blocker, pacemaker or ICD or CRT.

Exclusion Criteria:

  • Unable to perform treadmill exercise
  • Pregnancy
  • Recent myocardial infarction (within 3 months).
  • Clinically significant angina.
  • Hospitalization for heart failure requiring intravenous treatments within 30 days.
  • Allergy to fish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944229

Contacts
Contact: Ulrich Jorde, MD 12123054600 upj1@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Ulrich Jorde, MD     212-305-4600     upj1@columbia.edu    
Sponsors and Collaborators
Columbia University
GlaxoSmithKline
Investigators
Principal Investigator: Ulrich Jorde, MD Columbia University
  More Information

No publications provided

Responsible Party: Ulrich Peter Jorde, Associate Professor of Medicine at NYPH/CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT00944229     History of Changes
Other Study ID Numbers: AAAD7501, LVZ112854
Study First Received: February 12, 2009
Last Updated: November 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Heart Failure
omega 3
lovaza
VO2 max

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013