TEAR-AF-HFpEF

Not 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

Lead sponsor

Yunlong Wang

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

602

estimated

Study population

Atrial fibrillation, Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥28•EF ≥50%

Primary endpoint

•Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07630454

Org study IDTEAR-AF-HFpEF_V1

Timeline

Milestones

Study first posted2026-06-05actual

Last update posted2026-06-05actual

Study start2026-08-01estimated

Primary completion2029-08-01estimated

Study completion2029-12-01estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Atrial fibrillationHeart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Heart failure

Other (unclassified)

Cardiovascular outcomes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other clinical outcomes

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Time to Cardiovascular Death

Time frame:Day 1 through Week 52

time to event, event

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to Week 52

change from baseline, improvement

Other/protocol endpoint

Change in epicardial adipose tissue volume

Time frame:Baseline to Week 52

change from baseline, improvement

Heart failure

3 endpoints

Secondary/protocol endpoint

Time to First Hospitalization for Heart Failure

Time frame:Day 1 through Week 52

time to event, event

Secondary/protocol endpoint

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum NT-proBNP Concentration

Time frame:Baseline to Week 52

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline to Week 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Time frame:Day 91 through Week 52 after catheter ablation

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Time to Death From Any Cause

Time frame:Day 1 through Week 52

time to event, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Percentage of Monitoring Time Spent in AF (AF Burden)

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

descriptive

Secondary/protocol endpoint/low confidence

Change in left atrial volume index (LAVI)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Echocardiographic E/e' Ratio

Time frame:Baseline to Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.