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
This trial is active, not recruiting.
|Conditions||coronary artery disease, arrhythmia|
|Treatment||eicosapentanoic acid (epa) and docosahexanoic acid (dha).|
|Sponsor||Sheba Medical Center|
|Start date||November 2005|
|End date||November 2009|
|Trial size||105 participants|
|Trial identifier||NCT00290056, SHEBA-04-3494-DL-CTIL|
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, outcomes assessor)|
number of VT/VF episodes
time frame: continous
All-cause mortality, cardiac mortality, recurrent and myocardial infarction.
time frame: 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
Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.
time frame: time of the test
Male or female participants at least 18 years old.
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.
|Principal investigator||David Luria, MD|
|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.|
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