Omega 3 Fatty Acids and Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
omega 3 fatty acids
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring omega 3fatty acids
Eligibility 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
Sites / Locations
- Ninewells Hospital and medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A1
A2
Arm Description
1 g omega 3 fatty acid supplements
Outcomes
Primary Outcome Measures
recurrence of atrial fibrillation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00508248
Brief Title
Omega 3 Fatty Acids and Atrial Fibrillation
Official Title
Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2005 (undefined)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
omega 3fatty acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Description
1 g omega 3 fatty acid supplements
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3 fatty acids
Other Intervention Name(s)
Omacor
Intervention Description
1g daily
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
olive oil capsule
Primary Outcome Measure Information:
Title
recurrence of atrial fibrillation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Struthers, MD
Organizational Affiliation
University of Dundee
Official's Role
Study Director
Facility Information:
Facility Name
Ninewells Hospital and medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Omega 3 Fatty Acids and Atrial Fibrillation
We'll reach out to this number within 24 hrs