Current partner codePEPTIDESDE
NCT07715929·Phase 4·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

710

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Eligible obese patients (or overweight patients with a weight-related comorbidity) with symptomatic paroxysmal or persistent AF undergoing catheter ablation will be screened within 28 days before the procedure. After ablation with restoration of sinus rhythm, participants will be randomized 1:1 to (a) tirzepatide plus standardized lifestyle intervention and standard AF management, or (b) standardized lifestyle intervention and standard AF management alone. Randomization is stratified by study center, AF type (paroxysmal/persistent), baseline BMI, and diabetes status. A 90-day post-ablation blanking period (Day 0-90) is excluded from the primary efficacy assessment. The primary efficacy assessment window runs from Day 91 to Day 365. Tirzepatide is administered subcutaneously once weekly and titrated per the China NMPA label using an individualized dose-adjustment SOP, continuing through Week 52. Both groups receive guideline-directed periprocedural anticoagulation, standardized antiarrhythmic drug (AAD) use, an individualized exercise prescription, a modified Mediterranean diet (target intake = total energy expenditure - 500 kcal), and management of smoking, alcohol, comorbidities, sleep, and obstructive sleep apnea (OSA). Approximately 8-12 tertiary (Class 3A) hospitals in China with mature AF ablation teams will participate. Planned enrollment is 710 participants.

Interventions

Treatment arms and agents.

DRUG

Tirzepatide

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.

BEHAVIORAL

Structured Lifestyle Intervention

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.

Timeline

From registration to results.

  1. First posted

    Jul 21, 2026

  2. Study start

    Sep 1, 2026

  3. Primary completion

    Sep 1, 2029

  4. Study completion

    Dec 30, 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Day 91 through Week 52 after catheter ablation

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.

Secondary outcomes

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

Time frame · At Week 12, Week 26, and Week 52

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

Change in body weight

Time frame · Baseline to Week 52

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

Change in BMI

Time frame · Baseline to Week 52

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

Change in waist circumference

Time frame · Baseline to Week 52

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

Change in left atrial volume index (LAVI)

Time frame · Baseline to Week 52

Change in echocardiographic LAVI (mL/m²) from baseline to 52 weeks measured by core laboratory.

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

Time frame · Baseline to Week 52

Change in serum NT-proBNP concentration from baseline to 52 weeks, measured by central laboratory.

Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration

Time frame · Baseline to Week 52

Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to 52 weeks, measured by central laboratory.

Time to Cardiovascular Death

Time frame · Day 1 through Week 52

Time to cardiovascular death.

Time to Death From Any Cause

Time frame · Day 1 through Week 52

Time to death from any cause.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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 * Body weight criteria (aligned with NMPA-approved tirzepatide indication) meeting at least one of the following: BMI ≥28.0 kg/m² (obesity threshold per Chinese criteria), OR BMI ≥24.0 kg/m² and \<28.0 kg/m² (overweight per Chinese criteria) with at least one weight-related comorbidity: hypertension, dyslipidemia, type 2 diabetes mellitus (T2DM), obstructive sleep apnea syndrome (OSAS), or atherosclerotic cardiovascular disease (ASCVD) * 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) * Willing and able to understand the study procedures, provide written informed consent, and comply with all protocol requirements including 12-month follow-up visits * Capable of performing basic physical activity (no absolute contraindication to moderate-intensity aerobic exercise) Exclusion Criteria: Cardiovascular Exclusion Criteria * 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 * NYHA functional class III or IV heart failure * Significant structural heart disease: hypertrophic cardiomyopathy, valvular heart disease requiring intervention, congenital heart disease, myocarditis, or cardiac sarcoidosis * Acute coronary syndrome (ACS), ischemic stroke/TIA, or major cardiac surgery within 6 months prior to screening Tirzepatide-Specific Exclusion Criteria (per NMPA Prescribing Information) * Prior use of any GLP-1 receptor agonist (liraglutide, semaglutide, dulaglutide, exenatide, etc.) or GIP receptor agonist, or known hypersensitivity to tirzepatide or any excipient in the formulation * Personal or family (first-degree relative) history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) * History of acute pancreatitis or chronic pancreatitis, or current symptomatic cholelithiasis or cholecystitis * Type 1 DM * Severe gastrointestinal disease including severe gastroparesis, inflammatory bowel disease, or any condition that would substantially impair gastrointestinal motility or absorption General Exclusion Criteria * Use of any weight-loss medication (orlistat, phentermine, naltrexone/bupropion, or other anti-obesity agents) or participation in any weight-loss pharmacotherapy clinical trial within 3 months prior to screening * Severe hepatic insufficiency (Child-Pugh class C) or severe renal insufficiency (eGFR \<15 mL/min/1.73 m²) * Active malignancy (receiving systemic anti-cancer treatment or with life expectancy \<2 years due to malignancy) * Pregnancy, breastfeeding, or women of childbearing potential who are unwilling to use highly effective contraception throughout the study and for ≥1 month after the last dose of tirzepatide * Severe psychiatric disorder (schizophrenia, bipolar disorder, severe major depressive disorder) that would impair ability to comply with study procedures * Known allergy or sensitivity to adhesive patch materials (relevant to ECG monitoring patch components) * Any other condition that, in the opinion of the investigator, would make participation inadvisable or compromise the safety of the participant or the integrity of the study

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

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