The Modified "Pills-in-the-Pocket" Strategy
- Conditions
- Atrial Fibrillation (AF)
- Interventions
- Drug: use Amiodarone, Bisoprolol and Digoxin
- Registration Number
- NCT06657404
- Lead Sponsor
- Yumei Xue
- 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.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 328
(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.
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group use Amiodarone, Bisoprolol and Digoxin use Amiodarone, Bisoprolol and Digoxin control group use Amiodarone, Bisoprolol and Digoxin use Bisoprolol and Digoxin
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China