Atrial Fibrillation (AF)
Conditions
Keywords
Atrial fibrillation, AF
Brief summary
This is a multicentre, prospective, randomised controlled study of 328 patients with non-paroxysmal AF (within 5 years of first diagnosis of AF) with recurrent atrial arrhythmias after first catheter ablation, randomly divided in a 1:1 ratio into a study group treated with triple AADs (amiodarone + bisoprolol + digoxin) and a control group treated with conventional AADs (amiodarone + bisoprolol + digoxin). The study group was treated with triple AADs (amiodarone + bisoprolol) and the control group was treated with conventional AADs (amiodarone + bisoprolol) with the aim of comparing the efficacy and safety of the two groups in terms of reversion of SR, which may provide an effective option of pocket drug reversion for patients with recurrence of SR after AF catheter ablation. Translated with DeepL.com (free version)
Interventions
DRUGuse Amiodarone, Bisoprolol and Digoxin
Amiodarone 200mg tid orally for 1 week, then reduced to 200mg bid orally for another week. The dose of amiodarone will be reduced to 200mg bid orally for 1 week, and then 200mg qd maintenance treatment will be started in the 3rd week of dosing. Bisoprolol 2.5-5mg qd oral treatment, the specific dose is decided by the investigator. Digoxin 0.125mg qd orally.
Sponsors
Beijing Anzhen Hospital
Sir Run Run Shaw Hospital
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Zhongshan People's Hospital, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Jiangmen Central Hospital
Xiamen Cardiovascular Hospital
Yan 'an Hospital of Kunming City
Yumei Xue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Age ≥18 years; (2) Non-valvular, non-paroxysmal AF (within 5 years of the first diagnosis of AF) with recurrent atrial arrhythmia lasting for more than 24 hours after the first catheter ablation and not self-terminating; (3) Patients who are not taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, and who agree to receive AADs without contraindications to AADs; or patients who are taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, but have been off of them for more than 1 month. \-
Exclusion criteria
(1) Previous cardiac surgery, such as cardiac bypass grafting, mechanical valve or prosthetic valve replacement; (2) Combined cardiomyopathy (e.g. hypertrophic cardiomyopathy, dilated cardiomyopathy, ischaemic cardiomyopathy, etc.); (3) Cardiac ultrasound suggests that the diameter of the left atrium is ≥50mm or there are valvular changes in rheumatic heart disease; (4) Previous history of abnormal thyroid function; (5) Severe hepatic or renal insufficiency (eGFR \<15, Child Class 3), or history of renal dialysis; (6) Heart rate \<60 beats/minute, any degree of atrioventricular block, two-branch or three-branch block at the time of resumption of SR after catheter ablation; (7) Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III-IV after catheter ablation; (8) Participation in a clinical trial of another drug or device during the same period; (9) Abnormalities or diseases that, in the opinion of the investigator, should be excluded from enrolment in this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| converted to sinus rhythm | 1 month | Patients with recurrent atrial arrhythmia after catheter ablation for non-paroxysmal AF (within 5 years of history of first AF diagnosis) within 1 month converted to sinus rhythm using AADs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint event of bradycardia, cardiovascular hospitalisation or death | 1 month | Bradycardia: heart rate \<60 beats/minute, any degree of atrioventricular block and/or more than two-branch block, and prolonged QTc interval (\>500ms). Cardiovascular hospitalisation: defined as hospitalisation or emergency admission due to recurrence of atrial arrhythmia, heart failure or serious adverse effects of AADs during the follow-up period after enrolment; all treatments during the period of admission or admission to an emergency clinic count as one hospitalisation. Heart failure: defined as an episode of left or right ventricular failure requiring hospitalisation. Serious adverse events of AADs: Torsade de pointes (Tdp), ventricular tachycardia or atrial fibrillation, atrial flutter (atrioventricular (AV) conduction ratio of 1:1), third-degree AV block, sick sinus node syndrome, digitalis toxicity, and drug-induced heart failure were classified as serious adverse events of AADs. All possible endpoints were adjudicated by experts not involved in the diagnosis and treatment. |
Countries
China
Contacts
Primary ContactYumei Xue, phD
Outcome results
None listed