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

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: GlaxoSmithKline

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