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Omega 3 Polyunsaturated Fatty Acid Supplements (PUFAs) and Microvolt T Wave Alternans (TWA) in Patients With Ventricular Arrhythmia

NCT ID: NCT00507390

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-08-31

Brief Summary

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This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs concentrates are anti-arrhythmic in ventricular arrhythmic substrates.

Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.

Detailed Description

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Patients from the Department of Cardiology ICD out-patient clinic, Ninewells Hospital and Medical School, will be recruited. All these patients have a history of documented ventricular arrhythmia. Data from previous studies predict that 90% of these patients will have abnormal MTWA. A total of 45 ICD patients will be recruited. The study design will be a double blind randomised placebo controlled crossover design. A baseline MTWA test will be performed and patients with an abnormal test will be selected. The patients will be randomised to receive fish oil supplements (2g/day) or placebo for 8 weeks each. At the end of each intervention period, a repeat MWTA test will be performed. A 10 ml venous blood sampled will also be collected at baseline, and after each intervention period (3 samples in total). Patients in atrial fibrillation, frequent atrial or ventricular ectopics, or with ventricular pacing from the ICD, unstable angina, NYHA IV heart failure, pregnancy or child bearing potential will be excluded from the study.

End Points of the Study. The primary endpoint will be quantitative and qualitative measures of MTWA during n-3 PUFAs treatment compared to placebo.

Statistical Analysis: Quantitative differences in MTWA measurements will be analysed by a Student's t-test and qualitative differences by a chi squared test. A probability of 0.05% will be considered significant.

Conditions

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Arrhythmia Defibrillators, Implantable

Keywords

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fish oils

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

n-3 PUFAs

Group Type ACTIVE_COMPARATOR

n-3 polyunsaturated fatty acids (PUFAs)

Intervention Type DIETARY_SUPPLEMENT

2g n-3 PUFAs once daily for 8 weeks

A2

olive oil capsules

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

1 capsule day

Interventions

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n-3 polyunsaturated fatty acids (PUFAs)

2g n-3 PUFAs once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

olive oil

1 capsule day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omacor

Eligibility Criteria

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Inclusion Criteria

* implantable cardiovertor defibrillators
* microvolt Twave alternans positive

Exclusion Criteria

* unstable angina
* CHF
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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AChoy

Senior Clinical Lecturer and Honorary Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allan Struthers, MD

Role: STUDY_DIRECTOR

University of Dundee

Locations

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Ninewells Hospital and medical School

Dundee, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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200306ver2

Identifier Type: -

Identifier Source: org_study_id