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

ConditionsAtrial Fibrillation Obesity & Overweight Catheter Ablation

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorYunlong Wang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and ≤75 years at the time of screening

Documented symptomatic paroxysmal AF or persistent AF, confirmed by 12-lead ECG, Holter monitoring, or cardiac monitoring device, with documented AF episode duration ≥7 days (for persistent AF) and total AF history duration ≤5 years

Failed response to or intolerance of at least one antiarrhythmic drug (AAD), or explicit patient preference for a rhythm control strategy

Undergoing catheter ablation for AF at a participating center, with confirmed successful restoration of sinus rhythm at the end of the procedure (as determined by the operator)

Disqualifiers

Long-standing persistent AF: continuous AF duration ≥5 years prior to enrollment

Prior catheter ablation for AF or atrial flutter at any time

Left atrial anteroposterior diameter >55 mm (by transthoracic echocardiography at screening)

Left ventricular ejection fraction (LVEF) <35% at screening

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

710 Participants

are divided into 2 treatment groups

Group A: Tirzepatide + Lifestyle InterventionExperimental treatment 2 interventions

Group B: Lifestyle InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia

Any documented atrial arrhythmia - defined as AF, atrial flutter (AFL), or atrial tachycardia (AT) - lasting ≥30 seconds, in the absence of antiarrhythmic drug (AAD) use.

Time frame

Day 91 through Week 52 after catheter ablation

Secondary outcomes

Percentage of Monitoring Time Spent in Atrial Fibrillation (AF Burden)

Percentage of total monitoring time spent in AF, measured by 7-day ambulatory ECG patch.

Time frame

At Week 12, Week 26, and Week 52

Change in body weight

Absolute and percentage change in body weight from baseline to baseline to 52 weeks.

Time frame

Baseline to Week 52

Change in BMI

Change from baseline to 52 weeks in body mass index (kg/m²)

Time frame

Baseline to Week 52

Change in waist circumference

Change from baseline to 52 weeks waist circumference (cm).

Time frame

Baseline to Week 52

Other outcomes

Change in epicardial adipose tissue volume

Change in epicardial adipose tissue volume measured by cardiac CT from baseline to 12 months.

Time frame

Baseline to Week 52

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunlong Wang

Lead sponsor

Beijing Anzhen Hospital

Sponsor institution

Source ClinicalTrials.gov

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