About this trial
The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population.
The main questions it aims to answer are:
1. Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring? 2. Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone? 3. Does tirzepatide reduce AF recurrence and cardiovascular events during 12 months of follow-up? Researchers will conduct a multi-center, open-label, endpoint-blinded, randomized controlled trial in adults aged 18-80 years with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants will be randomized 1:1 to receive either tirzepatide plus standard peri-procedural and post-ablation care or standard care alone.
Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.
Eligibility criteria
Qualifiers
Age between 18 and 80 years.
Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).
Able and willing to provide written informed consent.
Disqualifiers
Long-standing AF or marked left atrial enlargement (persistent AF duration > 5 years or left atrial anterior-posterior diameter > 50 mm).
AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery).
Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy).
Planned major non-AF-related surgery or interventional procedure within 3 months.
Trial design
Treatments tested in this trial
- Tirzepatide
- Standard Care (in control arm)