Status:
UNKNOWN
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
Lead Sponsor:
Sheba Medical Center
Conditions:
Coronary Artery Disease
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 desi...
Eligibility Criteria
Inclusion
- post-MI patients.
- Both single and Dual chamber ICD recipient.
- implanted more than 3 months ago.
- Agree to give written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00290056
Start Date
November 1 2005
End Date
June 1 2010
Last Update
November 4 2009
Active Locations (2)
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1
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239.
2
Sheba Medical Center, Heart Institute, Electrophysiology Unit
Tel Litwinsky, Israel