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Omega 3 Fatty Acids and Atrial Fibrillation

This study has been withdrawn prior to enrollment.
(Funding)
Sponsor:
Information provided by (Responsible Party):
AChoy, University of Dundee
ClinicalTrials.gov Identifier:
NCT00508248
First received: July 25, 2007
Last updated: October 24, 2016
Last verified: October 2016

July 25, 2007
October 24, 2016
January 2005
January 2005   (final data collection date for primary outcome measure)
recurrence of atrial fibrillation [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00508248 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Omega 3 Fatty Acids and Atrial Fibrillation
Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atrial Fibrillation
  • Dietary Supplement: omega 3 fatty acids
    1g daily
    Other Name: Omacor
  • Dietary Supplement: placebo
    olive oil capsule
  • Active Comparator: A1
    1 g omega 3 fatty acid supplements
    Intervention: Dietary Supplement: omega 3 fatty acids
  • Placebo Comparator: A2
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2008
January 2005   (final data collection date for primary outcome measure)

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
Both
21 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00508248
270605ver3
Yes
Not Provided
Not Provided
AChoy, University of Dundee
University of Dundee
Not Provided
Study Director: Allan Struthers, MD University of Dundee
University of Dundee
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP