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

ConditionsAtrial Fibrillation Heart Failure With Preserved Ejection Fraction (HFpEF)Tirzepatide

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorYunlong Wang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 80 years

Symptomatic atrial fibrillation (paroxysmal or persistent of ≤ 5 years duration), undergoing first-time catheter ablation

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

602 Participants

are divided into 2 treatment groups

Group A: Tirzepatide + Lifestyle InterventionExperimental treatment 2 interventions

Group B: Lifestyle InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

Day 91 through Week 52 after catheter ablation

Secondary outcomes

Percentage of Monitoring Time Spent in AF (AF Burden)

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

Time frame

At Week 12, Week 26, and Week 52

Change in body weight

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

Time frame

Baseline to Week 52

Change in body mass index (BMI)

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

Time frame

Baseline to Week 52

Change in waist circumference

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

Time frame

Baseline to Week 52

Other outcomes

Change in epicardial adipose tissue volume

Change in epicardial adipose tissue volume measured by cardiac CT from baseline to 12 months.

Time frame

Baseline to Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunlong Wang

Lead sponsor

Beijing Anzhen Hospital

Sponsor institution

Shanghai Zhongshan Hospital

Collaborator

Source ClinicalTrials.gov

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