Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00004558
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antiarrhythmic Effects of N-3 Fatty Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2000-02-09', 'studyFirstSubmitQcDate': '2000-02-09', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Arrhythmia', 'Heart Diseases', 'Tachycardia, Ventricular', 'Ventricular Fibrillation']}, 'referencesModule': {'references': [{'pmid': '15956633', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.', 'detailedDescription': 'BACKGROUND:\n\nVentricular 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).\n\nDESIGN NARRATIVE:\n\nProspective, 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.\n\nThe study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'No eligibility criteria'}, 'identificationModule': {'nctId': 'NCT00004558', 'briefTitle': 'Antiarrhythmic Effects of N-3 Fatty Acids', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'orgStudyIdInfo': {'id': '126'}, 'secondaryIdInfos': [{'id': 'R01HL061682', 'link': 'https://reporter.nih.gov/quickSearch/R01HL061682', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dietary n-3 polyunsaturated fatty acids', 'type': 'BEHAVIORAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}}}}