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NOT YET RECRUITING
NCT07897305
NA

Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, superiority randomized controlled trial enrolling adult patients aged 18 to 75 years. All participants have abdominal obesity (BMI ≥ 28 kg/m² with specific waist circumference standards) and non-valvular atrial fibrillation, and have successfully regained normal heart rhythm after their first catheter ablation. The study aims to compare the efficacy and safety of weekly mazdutide injection with conventional routine care in preventing heart rhythm recurrence within 12 months after ablation (excluding a 3-month early recovery blanking period). A total of 24 months will be spent recruiting participants, followed by a 12-month follow-up period. Participants are randomly divided into two groups. The intervention group receives escalating-dose mazdutide subcutaneous injections starting within 48 hours after ablation alongside standard health guidance on diet, exercise and lifestyle. The control group only receives the same routine health guidance without mazdutide treatment. The primary efficacy endpoint is recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).

Official title: Efficacy of Mazdutide in Reducing Recurrence After Catheter Ablation in Obese Patients With Atrial Fibrillation: A Multicenter, Superiority, Open-label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2026-10-25

Completion Date

2028-12-30

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Mazdutide

1. Initiation of mazdutide subcutaneous injection within 48 hours after catheter ablation. Starting dose: 2 mg subcutaneously once weekly using a single-dose pen auto-injector. The initial dose is 2 mg once weekly, increased by 2 mg every 4 weeks during dose escalation, with a maximum dose of 6 mg. The target dose is individualized based on the patient's weight-loss effect. Once the patient achieves a 10% reduction in body weight, the dose is maintained for continued treatment. 2. Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.

OTHER

Conventional treatment

Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.

Locations (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.

Beijing, China