Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF

NCT07630454 · tracked via the Priya Life Science China tracker

Sponsor

Yunlong Wang

Phase

Phase 4

Started

2026-08-01

Last updated

2026-06-05

Condition(s) studied

Atrial FibrillationHeart Failure With Preserved Ejection Fraction (HFpEF)Tirzepatide

Investigational drug(s) / intervention(s)

Tirzepatide →Structured Lifestyle Intervention

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 (maximum 15 mg/week) over 12 weeks, then maintained at the maximum tolerated dose for the remainder of the 12-month treatment period.

Structured Lifestyle Intervention: Guideline-directed AF management (rate/rhythm control, anticoagulation by CHA2DS2-VASc). Guideline-directed HFpEF therapy (MRA, SGLT2 inhibitor as clinically indicated). Structured lifestyle intervention: monthly dietitian-led counseling targeting a 500 kcal/day caloric deficit; exercise prescription of ≥150 min/week moderate aerobic; smoking cessation and alcohol moderation counseling.

Study summary

This multicenter, randomized, open-label, blinded-endpoint trial evaluates whether weekly subcutaneous tirzepatide for 12 months reduces atrial fibrillation (AF) recurrence after catheter ablation in adults with obesity and heart failure with preserved ejection fraction (HFpEF). HFpEF is diagnosed by direct intraprocedural measurement of mean left atrial pressure (mLAP ≥ 15 mmHg at rest) during the ablation procedure, providing a hemodynamically anchored, homogeneous study population free from the diagnostic ambiguities of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and E/e' in AF patients. Approximately 602 participants will be randomized 1:1 to tirzepatide (titrated to a target of 10 mg/week, maximum 15 mg/week) plus standard care, or standard care alone. Both groups receive an identical structured lifestyle intervention. The primary endpoint is the first documented AF/atrial flutter/atrial tachycardia episode lasting ≥ 30 seconds, occurring between day 91 and day 365 after ablation, adjudicated by an independent blinded clinical endpoint committee.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age 18 to 80 years * Symptomatic atrial fibrillation (paroxysmal or persistent of ≤ 5 years duration), undergoing first-time catheter ablation * 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) * HFpEF defined by intraprocedural mean left atrial pressure ≥ 15 mmHg at rest * Left ventricular ejection fraction ≥ 50% on echocardiography within 30 days prior to enrollment * Provision of written informed consent Exclusion Criteria: * Prior use of any GLP-1 receptor agonist or GIP/GLP-1 dual receptor agonist * Type 1 diabetes mellitus; or type 2 diabetes with HbA1c \> 10% * Personal history of pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) * Severe gastrointestinal disease, including gastroparesis or active inflammatory bowel disease * Prior bariatric surgery * Moderate or severe valvular heart disease, hypertrophic cardiomyopathy, cardiac amyloidosis, constrictive pericarditis, or restrictive cardiomyopathy * Severe renal impairment (eGFR \< 30 mL/min/1.73m²) * Active malignancy, excluding basal cell carcinoma * Acute coronary syndrome, stroke, percutaneous coronary intervention, or cardiac surgery within 30 days prior to enrollment * Pregnancy, lactation, or planned pregnancy within 6 months * Life expectancy \< 12 months * Concurrent participation in another interventional clinical trial * Any condition that, in the investigator's judgment, would interfere with participation

Primary outcome measure(s)

Number of Participants With Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia — 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

Trial sites (1)

Facility	City	Region	Status
Beijing Anzhen Hospital	Beijing	Beijing Municipality

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07630454 on ClinicalTrials.gov ↗ ← All trials in China