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

This study has been withdrawn prior to enrollment.
(funding not secured)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507390
First Posted: July 26, 2007
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AChoy, University of Dundee
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 AChoy, University of Dundee:

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

Enrollment: 0
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • implantable cardiovertor defibrillators
  • microvolt Twave alternans positive

Exclusion Criteria:

  • unstable angina
  • CHF
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AChoy, Senior Clinical Lecturer and Honorary Consultant Cardiologist, University of Dundee
ClinicalTrials.gov Identifier: NCT00507390     History of Changes
Other Study ID Numbers: 200306ver2
First Submitted: July 25, 2007
First Posted: July 26, 2007
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AChoy, University of Dundee:
fish oils