Omega 3 Fatty Acids and Atrial Fibrillation

NCT00508248 | Withdrawn DMC

• 1 other identifier: 270605ver3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

omega 3fatty acids

Outcome Measures

Primary Outcomes (1)

• recurrence of atrial fibrillation

  6 months

Study Arms (2)

A1

ACTIVE COMPARATOR

1 g omega 3 fatty acid supplements

Dietary Supplement: omega 3 fatty acids

A2

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

omega 3 fatty acids DIETARY_SUPPLEMENT

1g daily

Also known as: Omacor

A1

placebo DIETARY_SUPPLEMENT

olive oil capsule

A2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrial fibrillation
• Post cardioversion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Ninewells Hospital and medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fatty Acids, Omega-3; Omacor

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Allan Struthers, MD

  University of Dundee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer and Honorary Consultant Cardiologist

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: January 1, 2005
• Primary Completion: January 1, 2005
• Study Completion: November 1, 2008
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

GB (1)