Omega 3 Fatty Acids and Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508248
Recruitment Status : Withdrawn (Funding)
First Posted : July 27, 2007
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
AChoy, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Dietary Supplement: omega 3 fatty acids Dietary Supplement: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation
Study Start Date : January 2005
Primary Completion Date : January 2005
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A1
1 g omega 3 fatty acid supplements
Dietary Supplement: omega 3 fatty acids
1g daily
Other Name: Omacor

Placebo Comparator: A2 Dietary Supplement: placebo
olive oil capsule

Primary Outcome Measures :
  1. recurrence of atrial fibrillation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508248

United Kingdom
Ninewells Hospital and medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Study Director: Allan Struthers, MD University of Dundee

Responsible Party: AChoy, Senior Clinical Lecturer and Honorary Consultant Cardiologist, University of Dundee Identifier: NCT00508248     History of Changes
Other Study ID Numbers: 270605ver3
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by AChoy, University of Dundee:
omega 3fatty acids

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes