The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive 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. Identifier: NCT00944229
Recruitment Status : Terminated (PI left the institution)
First Posted : July 23, 2009
Results First Posted : April 22, 2016
Last Update Posted : May 25, 2016
Information provided by (Responsible Party):
Columbia University

Brief Summary:

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.


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 or disease Intervention/treatment Phase
Heart Failure Drug: LOVAZA (Omega-3) Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ?
Study Start Date : January 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Peak VO2 [ Time Frame: 0, 1 and 8 weeks of Omega 3 supplementation. ]
  2. 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. ]
  3. Change 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. ]

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

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

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 identifier (NCT number): NCT00944229

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Ulrich Jorde, MD Columbia University

Responsible Party: Columbia University Identifier: NCT00944229     History of Changes
Other Study ID Numbers: AAAD7501
LVZ112854 ( Other Identifier: GSK protocol # )
First Posted: July 23, 2009    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: May 25, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases