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Antiarrhythmic Effects of N-3 Fatty Acids

Primary Purpose

Arrhythmia, Heart Diseases, Tachycardia, Ventricular

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dietary n-3 polyunsaturated fatty acids
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004558
    Brief Title
    Antiarrhythmic Effects of N-3 Fatty Acids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmia, Heart Diseases, Tachycardia, Ventricular, Ventricular Fibrillation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    dietary n-3 polyunsaturated fatty acids

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15956633
    Citation
    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. doi: 10.1001/jama.293.23.2884.
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    Antiarrhythmic Effects of N-3 Fatty Acids

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