Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507390
Status:
WITHDRAWN
Last Update Posted:
2016-10-26
First Post:
2007-07-25
Brief Title:
Omega 3 Polyunsaturated Fatty Acid Supplements PUFAs and Microvolt T Wave Alternans TWA in Patients With Ventricular Arrhythmia
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding not secured
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PUFAsday Omacor reduces MTWA a surrogate endpoint for ventricular arrhythmia substrate in patients with ICDs for malignant ventricular arrhythmias
Study Aims To investigate whether dietary supplements of n-3 polyunsaturated fatty acid concentrates 2g PUFAsday 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 2gday 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 Students t-test and qualitative differences by a chi squared test A probability of 005 will be considered significant
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 Students t-test and qualitative differences by a chi squared test A probability of 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None