Omega 3 Fatty Acids and Atrial Fibrillation

NCT ID: NCT00508248

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-11-30

Brief Summary

Unlike for ventricular arrhythmias, the role of n-3 PUFAs in atrial arrhythmias has not been fully investigated. A recently published epidemiological study reported that in elderly patients, consumption of fish was associated with a lower incidence of atrial fibrillation over the 12 years of follow-up. This observation may be an indirect effect due to the overall beneficial effort of fish consumption on reducing ischaemic heart disease, however this association persisted after adjustment for confounding characteristics. Clinical data regarding the direct impact of n-3 PUFAs on atrial arrhythmias such as atrial fibrillation/flutter (AF) is lacking. However, as both INa and ICa-L are also in atrial myocytes, similar anti-fibrillatory actions by n-3PUFAs would be expected in atrial fibrillation and we would like to investigate this further. The primary aim of this study is to investigate whether dietary supplements of n-3 PUFA concentrates (1g fish oil/day comprising eicosapentaenoic acid, EPA 46% and docosahexaenoic, DHA 38%)) helps maintain sinus rhythm after cardioversion to normal sinus rhythm in patients with persistent atrial fibrillation.

Detailed Description

The patients. Randomisation. Patients with persistent AF will be recruited from clinic attendees and in-patient hospital patients at Ninewells Hospital and Medical School. A total of 150 patients with AF of more than 7 days duration and scheduled for elective direct current cardioversion will be recruited. The patients will be randomised to receive fish oil supplements (3g/day) or placebo on recruitment for a period of 4 weeks prior to cardioversion and continued after cardioversion until recurrence of AF or until the end of 6 months. All patients will be anticoagulated routinely. Patients on anti-arrhythmic drugs, left atrial size >6 cm, significant mitral valve disease, myocardial infarction in the last 3 months, unstable angina, NYHA IV heart failure, cardiac surgery in the previous 3 months, acute reversible conditions, significant thyroid, hepatic, pulmonary disease, pregnancy or child bearing potential will be excluded from the study.

3.2. End Points of the Study. The primary endpoint will be time to first electrocardiographically confirmed recurrence of atrial fibrillation/flutter lasting more than 10 minutes. Secondary endpoints will be shock number and energy requirements to achieve electrical cardioversion. All patients will give informed consent and approval will be obtained from the Ethics Committee of Ninewells Hospital and Medical School.

3.3. Free n-3 PUFA plasma concentrations On the day of cardioversion, 3mls of venous blood will be obtained for measurement of free n-3 PUFA plasma concentrations.

3.4. Elective Direct current cardioversion and Follow-up Patients will be routinely scheduled for cardioversion (2 per week) as outpatients. Cardioversion will be under conscious sedation (titrated doses of intravenous midazolam) as is the current routine practice in the Department of Cardiology, Ninewells Hospital. Follow-up (with ECG) of cardioverted patients will be weekly in the first month; then 2,3,4,5 and 6 months; and at any time the patients complains of palpitations or other symptoms.

Conditions

Atrial Fibrillation

Keywords

omega 3fatty acids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A1

1 g omega 3 fatty acid supplements

Group Type: ACTIVE_COMPARATOR

omega 3 fatty acids

Intervention Type: DIETARY_SUPPLEMENT

1g daily

A2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

olive oil capsule

Interventions

omega 3 fatty acids

1g daily

Intervention Type: DIETARY_SUPPLEMENT

placebo

olive oil capsule

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Omacor

Eligibility Criteria

Inclusion Criteria

• Atrial fibrillation
• Post cardioversion

Exclusion Criteria

• Patients on anti-arrhythmic drugs
• Left atrial size > 6 cm
• Significant mitral valve disease
• Myocardial infarction in the last 3 months
• Unstable angina
• NYHA IV heart failure
• Cardiac surgery in the previous 3 months
• Acute reversible conditions
• Significant thyroid, hepatic, pulmonary disease
• Pregnancy or child bearing potential

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

AChoy

Senior Clinical Lecturer and Honorary Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan Struthers, MD

Role: STUDY_DIRECTOR

University of Dundee

Locations

Ninewells Hospital and medical School

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

270605ver3

Identifier Type: -

Identifier Source: org_study_id