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Antiarrhythmic Effects of N-3 Fatty Acids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004558
First Posted: February 10, 2000
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


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

Study Start Date: February 1999
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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004558     History of Changes
Other Study ID Numbers: 126
R01HL061682 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2000
First Posted: February 10, 2000
Last Update Posted: February 18, 2016
Last Verified: December 2005

Additional relevant MeSH terms:
Heart Diseases
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes