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Fatty Acid Antiarrhythmia Trial (FAAT)

Primary Purpose

Arrhythmia, Heart Diseases, Tachycardia, Ventricular

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dietary polyunsaturated fatty acid
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
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004559
    Brief Title
    Fatty Acid Antiarrhythmia Trial (FAAT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2002 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).
    Detailed Description
    BACKGROUND: Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. This project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted. DESIGN NARRATIVE: Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat. 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 3
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    dietary polyunsaturated fatty acid

    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
    16267249
    Citation
    Leaf A, Albert CM, Josephson M, Steinhaus D, Kluger J, Kang JX, Cox B, Zhang H, Schoenfeld D; Fatty Acid Antiarrhythmia Trial Investigators. Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake. Circulation. 2005 Nov 1;112(18):2762-8. doi: 10.1161/CIRCULATIONAHA.105.549527.
    Results Reference
    background

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    Fatty Acid Antiarrhythmia Trial (FAAT)

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