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

Sponsor
Yunlong Wang
Study ID
NCT07630454
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 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 (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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
602 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Tirzepatide + Lifestyle Intervention
    Participants receive subcutaneous tirzepatide once weekly for 12 months in addition to guideline-directed lifestyle intervention. Dose escalation: 2.5 mg/week for weeks 1-4; 5 mg/week for weeks 5-8; 7.5 mg/week for weeks 9-12; 10 mg/week from week 13 onward (target); may be escalated to 15 mg/week if tolerated. All participants additionally receive a structured lifestyle intervention identical to the control arm.
  • Active Comparator: Lifestyle Intervention
    Participants receive guideline-directed standard care for AF, anticoagulation, and HFpEF, without any GLP-1 receptor agonist or GIP/GLP-1 dual agonist. The same structured lifestyle intervention as the experimental arm is delivered, including monthly dietitian-led counseling, exercise prescription, and sleep apnea screening, to ensure equal follow-up intensity.

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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