NCT07630454Not yet recruitingPhase 4
Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF
Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Patients With Obese and HFpEF: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 602 (estimated)
- First submitted
- 27 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2029
- Lead sponsor
- Yunlong Wang
- Diseases
- Heart failure, Obesity, Atrial fibrillation
- NCT number
- NCT07630454
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 602
- From 1 Aug 2026 to the primary completion date, 1 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of any GLP-1 receptor agonist or GIP/GLP-1 dual receptor agonist
- Prior bariatric surgery
- Acute coronary syndrome, stroke, percutaneous coronary intervention, or cardiac surgery within 30 days prior to enrollment
- Concurrent participation in another interventional clinical trial
Other illness
- 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
- Moderate or severe valvular heart disease, hypertrophic cardiomyopathy, cardiac amyloidosis, constrictive pericarditis, or restrictive cardiomyopathy
- Active malignancy, excluding basal cell carcinoma
- Any condition that, in the investigator's judgment, would interfere with participation
Lab values
- Type 1 diabetes mellitus; or type 2 diabetes with HbA1c \> 10%
- Severe renal impairment (eGFR \< 30 mL/min/1.73m²)
Other
- Pregnancy, lactation, or planned pregnancy within 6 months
- Life expectancy \< 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.