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

November 3, 2009 updated by: Sheba Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel, 64239.
    - The Tel Aviv Sourasky Medical Center
  - Tel-Hashomer, Israel
    - Sheba Medical Center, Heart Institute, Electrophysiology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of VT/VF episodes Time Frame: continous	continous

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality, cardiac mortality, recurrent and myocardial infarction. Time Frame: continous	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. Time Frame: 24 hours	24 hours
Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging. Time Frame: time of the test	time of the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

Principal Investigator: David Luria, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria