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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Sheba Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00290056
First received: February 9, 2006
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.


Condition Intervention Phase
Coronary Artery Disease
Arrhythmia
Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • number of VT/VF episodes [ Time Frame: continous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality, cardiac mortality, recurrent and myocardial infarction. [ Time Frame: continous ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging. [ Time Frame: time of the test ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: November 2005
Estimated Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
    3.6 gram oral supplementation for 6 months.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290056

Locations
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239.
Sheba Medical Center, Heart Institute, Electrophysiology Unit
Tel-Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: David Luria, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dalit Weisman, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00290056     History of Changes
Other Study ID Numbers: SHEBA-04-3494-DL-CTIL
Study First Received: February 9, 2006
Last Updated: November 3, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
CHD
Arrhythmia
ICD
Omega-3 PUFA
Nutrition

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014