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
|ClinicalTrials.gov Identifier: NCT00290056|
Recruitment Status : Unknown
Verified November 2009 by Sheba Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 10, 2006
Last Update Posted : November 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Arrhythmia||Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).||Phase 4|
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:
- 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.
- The Hebrew language SF-36 health survey will be used to examine general health status.
- The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||June 2010|
Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290056
|The Tel Aviv Sourasky Medical Center|
|Tel Aviv, Israel, 64239.|
|Sheba Medical Center, Heart Institute, Electrophysiology Unit|
|Principal Investigator:||David Luria, MD||Sheba Medical Center|