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

Phase 4

Withdrawn

• Conditions: Arrhythmia; Defibrillators, Implantable
• Interventions: Dietary Supplement: n-3 polyunsaturated fatty acids (PUFAs); Dietary Supplement: olive oil

• Registration Number: NCT00507390
• Lead Sponsor: University of Dundee

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• implantable cardiovertor defibrillators
• microvolt Twave alternans positive

Exclusion Criteria

• unstable angina
• CHF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A1	n-3 polyunsaturated fatty acids (PUFAs)	n-3 PUFAs
A2	olive oil	olive oil capsules

Primary Outcome Measures

Name	Time	Method
Change in microvolt T wave alternans status	8 weeks

Trial Locations

Locations (1)

Ninewells Hospital and medical School; 🇬🇧 Dundee, United Kingdom