Full Text View
Tabular View
No Study Results Posted
Related Studies
Antiarrhythmic Effects of N-3 Fatty Acids
This study has been completed.
Study NCT00004558   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: February 9, 2000   Last Updated: January 3, 2006   History of Changes

February 9, 2000
January 3, 2006
February 1999
 
 
Complete list of historical versions of study NCT00004558 on ClinicalTrials.gov Archive Site
 
 
 
Antiarrhythmic Effects of N-3 Fatty Acids
 

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

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.

Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control
  • Arrhythmia
  • Heart Diseases
  • Tachycardia, Ventricular
  • Ventricular Fibrillation
Behavioral: dietary n-3 polyunsaturated fatty acids
 
Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2884-91.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
January 2004
 

No eligibility criteria

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004558
 
126
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP