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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

Short name TEAR-AF-HFpEF

NCTNCT07630454 (opens ClinicalTrials.gov in a new tab)Other idTEAR-AF-HFpEF_V1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
602 participants (estimated)
Sponsor
Yunlong Wang · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
1 Aug 2026 (estimated)
Primary completion
1 Aug 2029 (estimated)
Completion
1 Dec 2029 (estimated)
First posted
5 Jun 2026
Last update posted
5 Jun 2026
Conditions
Atrial Fibrillation · Heart Failure With Preserved Ejection Fraction (HFpEF) · Tirzepatide

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 4

    TEAR-AF-HFpEF

    NCT07630454

    est. 1 Aug 2026 to est. 1 Dec 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • Structured Lifestyle InterventionBehavioral

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia

    Time frame · Day 91 through Week 52 after catheter ablation

    Registry description

    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(12)

  1. Percentage of Monitoring Time Spent in AF (AF Burden)

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

    Registry description

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

  2. Change in body weight

    Time frame · Baseline to Week 52

    Registry description

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

  3. Change in body mass index (BMI)

    Time frame · Baseline to Week 52

    Registry description

    Change from baseline to 52 weeks in BMI (kg/m²)

  4. Change in waist circumference

    Time frame · Baseline to Week 52

    Registry description

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

  5. Change in left atrial volume index (LAVI)

    Time frame · Baseline to Week 52

    Registry description

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

  6. Change in Echocardiographic E/e' Ratio

    Time frame · Baseline to Week 52

    Registry description

    Change in echocardiographic E/e' from baseline to 52 weeks, measured by core laboratory.

  7. Time to First Hospitalization for Heart Failure

    Time frame · Day 1 through Week 52

    Registry description

    Time to first hospitalization for heart failure, adjudicated by the CEC.

  8. Time to Cardiovascular Death

    Time frame · Day 1 through Week 52

    Registry description

    Time to cardiovascular death

  9. Time to Death From Any Cause

    Time frame · Day 1 through Week 52

    Registry description

    Time to death from any cause.

  10. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

    Time frame · Baseline to Week 52

    Registry description

    Change in KCCQ overall summary score and clinical summary score from baseline to 52 weeks. Both scores range from 0 to 100, with higher scores indicating better health status (fewer symptoms, less physical limitation, and better quality of life).

  11. Change in Serum NT-proBNP Concentration

    Time frame · Baseline to Week 52

    Registry description

    Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to 52 weeks, measured by central laboratory.

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

    Time frame · Baseline to Week 52

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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