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

Arrhythmia Clinical Trial

Official title:

The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00507390
• Other study ID #: 200306ver2
• Status: Withdrawn
• Phase: Phase 4
• First received: July 25, 2007
• Last updated: October 24, 2016
• Start date: January 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2016
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• implantable cardiovertor defibrillators

• microvolt Twave alternans positive

Exclusion Criteria:

• unstable angina

• CHF

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Defibrillators, Implantable

Intervention

Dietary Supplement:
• n-3 polyunsaturated fatty acids (PUFAs)
2g n-3 PUFAs once daily for 8 weeks
• olive oil
1 capsule day

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital and medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microvolt T wave alternans status		8 weeks