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 - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00290056

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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Coronary Artery Disease Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

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 ]
The effect of omega-3 PUFA supplementation on C-reactive protein blood levels. [ Time Frame: not pertinent ] [ Designated as safety issue: No ]

Estimated Enrollment:	112
Study Start Date:	November 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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.

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

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

Locations

Israel
Sheba Medical Center, Heart Institute, Electrophysiology Unit
Tel-Hashomer, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239.

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

David Luria, MD

Sheba Medical Center

More Information

No publications provided

Responsible Party:	Sheba Medical Center ( Dalit Weisman )
Study ID Numbers:	SHEBA-04-3494-DL-CTIL
Study First Received:	February 9, 2006
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00290056 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

CHD
Arrhythmia
ICD
Omega-3 PUFA
Nutrition

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Coronary Artery Disease
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Pathologic Processes
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009