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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00004558 |
To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.
Condition | Intervention | Phase |
---|---|---|
Arrhythmia Heart Diseases Tachycardia, Ventricular Ventricular Fibrillation |
Behavioral: dietary n-3 polyunsaturated fatty acids |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Study Start Date: | February 1999 |
Estimated Study Completion Date: | January 2004 |
BACKGROUND:
Ventricular tachycardia (VT) and ventricular fibrillation (VF) are common causes of the 300,000 sudden deaths occurring in the United States each year. Most of these victims have associated heart disease, most commonly coronary artery disease. Populations consuming considerable quantities of fish and marine mammals have lower than expected mortality rates from coronary disease. Interventional and observational trials have indicated that fatty fish consumption decreases the death rate from coronary artery disease, in part by reducing the number of sudden deaths. Animal and tissue culture studies both support the hypothesis that these beneficial effects are from the antiarrhythmic properties of n-3 long chained polyunsaturated fatty acids (eicosapentaenoic and docosahexaenoic acids).
DESIGN NARRATIVE:
Prospective, randomized, double blinded trial. Survivors of VT and VF with an implantable defibrillator were randomized, 100 to dietary supplementation with n-3 polyunsaturated fatty acids(PUFA) or 100 to a placebo. Adherence to the supplement were assessed by measurements of plasma, red cell, and adipose tissue n-3 fatty acid concentrations. The primary outcome variable was the incidence of recurrent VT or VF, but secondary variables were also assessed using serial implantable cardioverter defibrillator (ICD) assessment, correlation of the rhythms with the biochemical measurements of n-3 fatty acids, hospitalization rates and quality of life. The (ICD) was the best protection available to patients and stored rhythm electrograms which allowed documentation of rhythm endpoints.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 126 |
Study First Received: | February 9, 2000 |
Last Updated: | January 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00004558 History of Changes |
Health Authority: | United States: Federal Government |
Paroxysmal Ventricular Fibrillation Heart Diseases Tachycardia Omega 3 Fatty Acid |
Anti-Arrhythmia Agents Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Tachycardia Cardiovascular Diseases |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |