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

NCT07630454 · Not yet recruiting

Last updated 2026-07-13

This clinical trial is testing whether the medication tirzepatide can reduce the recurrence of atrial fibrillation in people with obesity and heart failure with preserved ejection fraction who have undergone catheter ablation.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, single-blind prevention study

Participants 602 people Planned (estimated).

Who can join Ages 18–80 · all sexes

Timeline Started 2026-08 · est. completion 2029-12

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07630454 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide also known as Mounjaro 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 (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 Behavioral

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.

Main thing measured	Number of Participants With Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia
Sponsor	Yunlong Wang
Conditions studied	Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFpEF), Tirzepatide
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07630454 ↗