Atrial Fibrillation Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |