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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00004559 |
Purpose
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).
| Condition | Intervention | Phase |
|
Arrhythmia Heart Diseases Tachycardia, Ventricular Ventricular Fibrillation |
Behavioral: dietary polyunsaturated fatty acid |
Phase III |
| Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
| MedlinePlus related topics: | Arrhythmia Heart Diseases |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| Study Start Date: | March 1999 |
| Estimated Study Completion Date: | February 2002 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
No eligibility criteria
Contacts and Locations More Information
| Study ID Numbers: | 127 |
| First Received: | February 9, 2000 |
| Last Updated: | November 10, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004559 |
| Health Authority: | United States: Federal Government |
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