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Home > "A" Clinical Trials Conditions > Antiarrhythmic Effects of N-3 Fatty Acids  Antiarrhythmic Effects of N-3 Fatty Acids
Antiarrhythmic Effects of N-3 Fatty Acids
For Condition: Ventricular Fibrillation,Heart Diseases,Arrhythmia,Tachycardia, Ventricular
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.
Details: 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 will be randomized to dietary supplementation with n-3 polyunsaturated fatty acids(PUFA) or to a placebo. Adherence to the supplement will be assessed by measurements of plasma, red cell, and adipose tissue n-3 fatty acid concentrations. The primary outcome variable will be the incidence of recurrent VT or VF, but secondary variables will also be 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) is the best protection available to patients and can store rhythm electrograms which will allow documentation of rhythm endpoints.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 126;
Study Start Date: February 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004558
Other Arrhythmia Studies:
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2. Psychophysiology of Cardiovascular Reactivity
3. Epidemiology of Stress and the Metabolic Syndrome
4. NHLBI Type II Coronary Intervention Study
5. Inflammation Markers Over Time in Cardiovascular Disease
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Antiarrhythmic Effects of N-3 Fatty Acids
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