NCT00290056

Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.

Detailed description

This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments. Randomization will be stratified by ejection fraction (≤ 35% or \> 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II). Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion). Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain. Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC). Three different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation: 1. The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary intake of other nutritional habits/patterns and its relationship to the study outcomes. 2. The Hebrew language SF-36 health survey will be used to examine general health status. 3. The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.

Conditions

• Coronary Artery Disease
• Arrhythmia

Interventions

Type	Name	Description
DRUG	Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).	3.6 gram oral supplementation for 6 months.

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-11-01
• Completion: 2010-06-01
• First posted: 2006-02-10
• Last updated: 2009-11-04

Locations

2 sites across 1 country: Israel