The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- University of Dundee
- Locations
- 1
- Primary Endpoint
- Change in microvolt T wave alternans status
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •implantable cardiovertor defibrillators
- •microvolt Twave alternans positive
Exclusion Criteria
- •unstable angina
Arms & Interventions
A1
n-3 PUFAs
Intervention: n-3 polyunsaturated fatty acids (PUFAs) (Dietary Supplement)
A2
olive oil capsules
Intervention: olive oil (Dietary Supplement)
Outcomes
Primary Outcomes
Change in microvolt T wave alternans status
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
AChoy
Senior Clinical Lecturer and Honorary Consultant Cardiologist
University of Dundee