Status:
TERMINATED
The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
Lead Sponsor:
Columbia University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00944229
Start Date
January 1 2010
End Date
March 1 2014
Last Update
May 25 2016
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032