Heart Failure
Conditions
Keywords
Heart Failure, omega 3, lovaza, VO2 max
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. 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.
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.
Interventions
DRUGLOVAZA (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).
DRUGPlacebo
4 capsules of placebo every 24 hours
Sponsors
GlaxoSmithKline
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Peak VO2 | 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. | 0 and after 8 weeks of Omega 3 supplementation. |
| Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise | 0, 1 and 8 weeks of Omega 3 supplementation. |
Countries
United States
Participant flow
Recruitment details
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Participants by arm
| Arm | Count |
|---|---|
| LOVAZA or Placebo Data per arm is not available. Columbia will never have access to this data. | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 14 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | LOVAZA or Placebo |
|---|---|
| Age, Customized >=65 years | 8 participants |
| Age, Customized Between 18 and 65 years | 50 participants |
| Race/Ethnicity, Customized African American | 13 participants |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Caucasian | 28 participants |
| Race/Ethnicity, Customized Hispanic | 14 participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Primary
Change in Peak VO2
Time frame: 0, 1 and 8 weeks of Omega 3 supplementation.
Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Primary
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.
Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.