Omega 3 Polyunsaturated Fatty Acid Supplements (PUFAs) and Microvolt T Wave Alternans (TWA) in Patients With Ventricular Arrhythmia
Primary Purpose
Arrhythmia, Defibrillators, Implantable
Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
n-3 polyunsaturated fatty acids (PUFAs)
olive oil
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia focused on measuring fish oils
Eligibility Criteria
Inclusion Criteria:
- implantable cardiovertor defibrillators
- microvolt Twave alternans positive
Exclusion Criteria:
- unstable angina
- CHF
Sites / Locations
- Ninewells Hospital and medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A1
A2
Arm Description
n-3 PUFAs
olive oil capsules
Outcomes
Primary Outcome Measures
Change in microvolt T wave alternans status
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00507390
Brief Title
Omega 3 Polyunsaturated Fatty Acid Supplements (PUFAs) and Microvolt T Wave Alternans (TWA) in Patients With Ventricular Arrhythmia
Official Title
The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
funding not secured
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Defibrillators, Implantable
Keywords
fish oils
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Description
n-3 PUFAs
Arm Title
A2
Arm Type
Placebo Comparator
Arm Description
olive oil capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 polyunsaturated fatty acids (PUFAs)
Other Intervention Name(s)
Omacor
Intervention Description
2g n-3 PUFAs once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil
Intervention Description
1 capsule day
Primary Outcome Measure Information:
Title
Change in microvolt T wave alternans status
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
implantable cardiovertor defibrillators
microvolt Twave alternans positive
Exclusion Criteria:
unstable angina
CHF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Struthers, MD
Organizational Affiliation
University of Dundee
Official's Role
Study Director
Facility Information:
Facility Name
Ninewells Hospital and medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Omega 3 Polyunsaturated Fatty Acid Supplements (PUFAs) and Microvolt T Wave Alternans (TWA) in Patients With Ventricular Arrhythmia
We'll reach out to this number within 24 hrs