Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00004559
Study type Interventional
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status Completed
Phase Phase 3
Start date March 1999
Completion date February 2002

See also
  Status Clinical Trial Phase
Completed NCT04624412 - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2 N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT04561908 - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access N/A
Active, not recruiting NCT06190743 - Perception of Cardiovascular Risk
Completed NCT04562636 - Evaluating a Messaging Campaign in the United States N/A
Completed NCT04580095 - Artificial Intelligence for Improved Echocardiography N/A
Recruiting NCT03277365 - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies N/A
Active, not recruiting NCT05553106 - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02046902 - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed NCT01909349 - Web-based Aftercare Intervention for Cardiac Patients N/A
Completed NCT01944254 - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients N/A
Recruiting NCT01457586 - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery Phase 4
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Terminated NCT00968383 - Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment N/A