The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
|ClinicalTrials.gov 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
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.
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
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
4 capsules of placebo every 24 hours
- Change in Peak VO2 [ Time Frame: 0, 1 and 8 weeks of Omega 3 supplementation. ]
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944229
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Ulrich Jorde, MD||Columbia University|