Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00508248
Status:
WITHDRAWN
Last Update Posted:
2016-10-26
First Post:
2007-07-25
Brief Title:
Omega 3 Fatty Acids and Atrial Fibrillation
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
Use of Omega 3 Polyunsaturated Fatty Acids Supplements to Maintain Sinus Rhythm in Persistent Atrial Fibrillation
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 fibrillationflutter 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 oilday 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 3gday 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
32 End Points of the Study The primary endpoint will be time to first electrocardiographically confirmed recurrence of atrial fibrillationflutter 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
33 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
34 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 2345 and 6 months and at any time the patients complains of palpitations or other symptoms
32 End Points of the Study The primary endpoint will be time to first electrocardiographically confirmed recurrence of atrial fibrillationflutter 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
33 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
34 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 2345 and 6 months and at any time the patients complains of palpitations or other symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None