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
- Conditions
- Coronary Artery DiseaseArrhythmia
- Registration Number
- NCT00290056
- Lead Sponsor
- Sheba Medical Center
- 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:
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
- post-MI patients.
- Both single and Dual chamber ICD recipient.
- implanted more than 3 months ago.
- Agree to give written informed consent.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method number of VT/VF episodes continous
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
The Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Sheba Medical Center, Heart Institute, Electrophysiology Unit
🇮🇱Tel-Hashomer, Israel