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

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: Coronary Artery Disease; Arrhythmia
• 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:

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

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	continous

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: David Luria, MD, Sheba Medical Center

Study record dates

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: February 9, 2006
• First Posted (Estimate): February 10, 2006

Study Record Updates

• Last Update Posted (Estimate): November 4, 2009
• Last Update Submitted That Met QC Criteria: November 3, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Arrhythmia; Nutrition; ICD; CHD; Omega-3 PUFA
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Arrhythmias, Cardiac
• Other Study ID Numbers: SHEBA-04-3494-DL-CTIL