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
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|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).
3.6 gram oral supplementation for 6 months.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|