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

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00507390
First received: July 25, 2007
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Arrhythmia
Defibrillators, Implantable
Dietary Supplement: n-3 polyunsaturated fatty acids (PUFAs)
Dietary Supplement: olive oil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Change in microvolt T wave alternans status [ Time Frame: 8 weeks ]

Estimated Enrollment: 45
Study Start Date: January 2007
Study Completion Date: August 2008
Arms Assigned Interventions
Active Comparator: A1
n-3 PUFAs
Dietary Supplement: n-3 polyunsaturated fatty acids (PUFAs)
2g n-3 PUFAs once daily for 8 weeks
Other Name: Omacor
Placebo Comparator: A2
olive oil capsules
Dietary Supplement: olive oil
1 capsule day

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • implantable cardiovertor defibrillators
  • microvolt Twave alternans positive

Exclusion Criteria:

  • unstable angina
  • CHF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507390

Locations
United Kingdom
Ninewells Hospital and medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Investigators
Study Director: Allan Struthers, MD University of Dundee
  More Information

No publications provided

Responsible Party: Anna Maria Choy, University of Dundee
ClinicalTrials.gov Identifier: NCT00507390     History of Changes
Other Study ID Numbers: 200306ver2
Study First Received: July 25, 2007
Last Updated: February 26, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
fish oils

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014