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

Heart Failure Clinical Trial

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 ?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00944229
• Other study ID #: AAAD7501
• Secondary ID: LVZ112854
• Status: Terminated
• Phase: Phase 3
• First received: February 12, 2009
• Last updated: April 16, 2015
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
4 capsules of placebo every 24 hours

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak VO2		0, 1 and 8 weeks of Omega 3 supplementation.	No
Primary	Change in reactive hyperemia peripheral arterial tonometry (RH-PAT) after 8 weeks of Omega 3 supplementation.		0 and after 8 weeks of Omega 3 supplementation.	No
Primary	Change in base line oxidized low density lipoprotein (LDL) level and in response to exercise		0, 1 and 8 weeks of Omega 3 supplementation.	No