Omega 3 Fatty Acids and Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University of Dundee.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00508248
First received: July 25, 2007
Last updated: July 26, 2007
Last verified: July 2007
  Purpose

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 Intervention
Atrial Fibrillation
Dietary Supplement: omega 3 fatty acids
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Dundee:

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

Estimated Enrollment: 180
Study Start Date: June 2005
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508248

Contacts
Contact: Anna Maria Choy, MD (44)1382632180 A.Choy@dundee.ac.uk
Contact: Chim c Lang, MD (44)1382 496375 c.c.lang@dundee.ac.uk

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

No publications provided

ClinicalTrials.gov Identifier: NCT00508248     History of Changes
Other Study ID Numbers: 270605ver3
Study First Received: July 25, 2007
Last Updated: July 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
omega 3fatty acids

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

ClinicalTrials.gov processed this record on April 20, 2014