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Antiarrhythmic Effects of N-3 Fatty Acids

This study has been completed.
Information provided by National Heart, Lung, and Blood Institute (NHLBI)

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Descriptive Information Fields
Brief Title  Antiarrhythmic Effects of N-3 Fatty Acids
Official Title 
Brief Summary

To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Double-Blind, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Arrhythmia
Heart Diseases
Tachycardia, Ventricular
Ventricular Fibrillation
Intervention  Behavioral: dietary n-3 polyunsaturated fatty acids
MEDLINE PMIDs 15956633
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  February 1999
Completion Date January 2004
Eligibility Criteria 

No eligibility criteria

Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00004558
Organization ID 126
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date December 2005
First Received Date  February 9, 2000
Last Updated Date January 3, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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