Omega 3 Fatty Acids and Atrial Fibrillation
Information source: University of Dundee
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: omega 3 fatty acids (Dietary Supplement); placebo (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: University of Dundee Official(s) and/or principal investigator(s): Allan Struthers, MD, Study Director, Affiliation: University of Dundee
Overall contact: Anna Maria Choy, MD, Phone: (44)1382632180, Email: A.Choy@dundee.ac.uk
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.
Clinical Details
Official title: Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: recurrence of 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Anna Maria Choy, MD, Phone: (44)1382632180, Email: A.Choy@dundee.ac.uk
Ninewells Hospital and medical School, Dundee DD1 9SY, United Kingdom; Recruiting
Additional Information
Starting date: June 2005
Last updated: July 26, 2007
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