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

Study Overview
=================
Brief 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: 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. The Hebrew language SF-36 health survey will be used to examine general health status. The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.

Conditions
-----------------
Coronary Artery Disease, Arrhythmia

Intervention / Treatment
-----------------
* Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-MI patients. Both single and Dual chamber ICD recipient. implanted more than 3 months ago. Agree to give written informed consent. Exclusion Criteria: Less than 18 years of age. ICD implantation as a 'bridge' to heart transplantation. Stable antiarrhythmic medication over the last month prior to enrollment. Patients taking class I antiarrhythmic medication. A projected lifespan less than one year. Participation in another trial (during or within 90 days before the study). Use of supplemental n-3 fatty acids during the last 3 months. Women who are pregnant and of childbearing potential who do not use adequate contraception. Patients known to have a history of recent drug or alcohol abuse. 10) History or current intestinal or hepatic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).|3.6 gram oral supplementation for 6 months.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of VT/VF episodes |  | continous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality, cardiac mortality, recurrent and myocardial infarction. |  | continous | 
| Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording. |  | 24 hours | 
| Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging. |  | time of the test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHD, Arrhythmia, ICD, Omega-3 PUFA, Nutrition