Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients

Sponsor
Yunlong Wang
Study ID
NCT07715929
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Dual GIP and GLP-1 receptor agonist administered as a weekly subcutaneous injection. Titrated from 2.5 mg/week to a target of 10 mg/week over 12 weeks, then maintained at the maximum tolerated dose for the remainder of the 52-week treatment period.
  • Structured Lifestyle Intervention — BEHAVIORAL
    Guideline-directed AF management (rate/rhythm control, anticoagulation by CHA2DS2-VASc). Structured lifestyle intervention: 500 kcal/day caloric deficit; exercise prescription of ≥150 min/week moderate aerobic; smoking cessation and alcohol moderation counseling.

Study Details

Obese patients with atrial fibrillation (AF) have a high recurrence rate after catheter ablation, even at experienced centers. Weight reduction improves post-ablation outcomes, but lifestyle measures alone are difficult to sustain. Tirzepatide, a once-weekly GIP/GLP-1 dual receptor agonist, produces greater weight loss than GLP-1 monotherapy and may confer additional cardiometabolic benefits. This multicenter, randomized, open-label, parallel-group, superiority trial evaluates whether adding standardized tirzepatide treatment to a structured lifestyle intervention - compared with the lifestyle intervention alone - reduces AF recurrence within 1 year after ablation in obese patients.

Key Dates

First listed
Jul 21, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
710 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide + Lifestyle Intervention
    Standardized lifestyle intervention and standard AF management plus once-weekly subcutaneous tirzepatide, initiated after randomization and continued through Week 52. Tirzepatide titration (per NMPA label): * Weeks 1-4: 2.5 mg once weekly (initiation) * Weeks 5-16: escalate by 2.5 mg every 4 weeks (5 mg → 7.5 mg → 10 mg) * Weeks 17-52: maintenance 10 mg once weekly, up-titratable to 15 mg (maximum dose 15 mg)
  • Active Comparator: Lifestyle Intervention
    AF Management and Post-Ablation Care * Ablation technique: circumferential pulmonary vein isolation (CPVI) ± adjunctive linear ablation at operator discretion, using established mapping and energy delivery protocols * Peri-procedural anticoagulation: guideline-directed anticoagulation * Antiarrhythmic drug (AAD) use: standardized per protocol SOP; Exercise Intervention • Target: moderate-intensity aerobic exercise ≥150 minutes per week, OR vigorous-intensity aerobic exercise ≥75 minutes per week Dietary Intervention • Caloric target: estimated total energy expenditure (TEE) minus 500 kcal/day Other Risk Factor Management * Smoking cessation * Alcohol restriction * Comorbidity management * OSA management

Primary Outcome Measure

Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia [ Time Frame: Day 91 through Week 52 after catheter ablation ]

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