Overview

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 Clin

Status:
Unknown status
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
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.