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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 9, 2000 |
| Last Updated Date | January 3, 2006 |
| Start Date ICMJE | February 1999 |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00004558 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Antiarrhythmic Effects of N-3 Fatty Acids |
| Official Title ICMJE | |
| 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. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control |
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: dietary n-3 polyunsaturated fatty acids |
| Study Arms / Comparison Groups | |
| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | January 2004 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Both |
| Ages | 18 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00004558 |
| Responsible Party | |
| Study ID Numbers ICMJE | 126 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | December 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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