The Modified "Pills-in-the-Pocket" Strategy (ABD-AF)
The Modified "Pills-in-the-Pocket" Strategy -The Combined Effect of Amiodarone, Bisoprolol and Digoxin in the Treatment of Recurrent Atrial Arrhythmia for Non-Paroxysmal Atrial Fibrillation After Catheter Ablation: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Clinical Trial
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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Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yumei Xue, phD
- Phone Number: 13570082363
- Email: xymgdci@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Guangdong Provincial People's Hospital
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Contact:
- Yumei Xue, phD
- Phone Number: 13570082363
- Email: xymgdci@163.com
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Contact:
- Haowei Chen, master
- Phone Number: 13026740170
- Email: 13026740170@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
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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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
use 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. |
|
Active Comparator: control group
use 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
converted to sinus rhythm
Time Frame: 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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite endpoint event of bradycardia, cardiovascular hospitalisation or death
Time Frame: 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. |
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Neurotransmitter Agents
- Anti-Arrhythmia Agents
- Sodium Channel Blockers
- Membrane Transport Modulators
- Cytochrome P-450 Enzyme Inhibitors
- Protective Agents
- Adrenergic Agents
- Cardiotonic Agents
- Vasodilator Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Antihypertensive Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Potassium Channel Blockers
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Digoxin
- Amiodarone
- Bisoprolol
Other Study ID Numbers
- 202332
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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