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Antiarrhythmic Effects of N-3 Fatty Acids
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00004558
  Purpose

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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1999
Estimated Study Completion Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study ID Numbers: 126
Study First Received: February 9, 2000
Last Updated: January 3, 2006
ClinicalTrials.gov Identifier: NCT00004558  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Tachycardia
Paroxysmal ventricular fibrillation
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009