Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients

Korábbi kezelés

• Long-standing persistent AF: continuous AF duration ≥5 years prior to enrollment
• Prior catheter ablation for AF or atrial flutter at any time
• Acute coronary syndrome (ACS), ischemic stroke/TIA, or major cardiac surgery within 6 months prior to screening
  • Tirzepatide-Specific Exclusion Criteria (per NMPA Prescribing Information)
• Prior use of any GLP-1 receptor agonist (liraglutide, semaglutide, dulaglutide, exenatide, etc.) or GIP receptor agonist, or known hypersensitivity to tirzepatide or any excipient in the formulation
• Use of any weight-loss medication (orlistat, phentermine, naltrexone/bupropion, or other anti-obesity agents) or participation in any weight-loss pharmacotherapy clinical trial within 3 months prior to screening
• Active malignancy (receiving systemic anti-cancer treatment or with life expectancy <2 years due to malignancy)

Más betegség

• NYHA functional class III or IV heart failure
• Significant structural heart disease: hypertrophic cardiomyopathy, valvular heart disease requiring intervention, congenital heart disease, myocarditis, or cardiac sarcoidosis
• Personal or family (first-degree relative) history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
• History of acute pancreatitis or chronic pancreatitis, or current symptomatic cholelithiasis or cholecystitis
• Severe gastrointestinal disease including severe gastroparesis, inflammatory bowel disease, or any condition that would substantially impair gastrointestinal motility or absorption
  • General Exclusion Criteria
• Severe psychiatric disorder (schizophrenia, bipolar disorder, severe major depressive disorder) that would impair ability to comply with study procedures
• Known allergy or sensitivity to adhesive patch materials (relevant to ECG monitoring patch components)
• Any other condition that, in the opinion of the investigator, would make participation inadvisable or compromise the safety of the participant or the integrity of the study

Laborértékek

• Left ventricular ejection fraction (LVEF) <35% at screening
• Severe hepatic insufficiency (Child-Pugh class C) or severe renal insufficiency (eGFR <15 mL/min/1.73 m²)

Egyéb

• Cardiovascular Exclusion Criteria
• Left atrial anteroposterior diameter >55 mm (by transthoracic echocardiography at screening)
• Type 1 DM
• Pregnancy, breastfeeding, or women of childbearing potential who are unwilling to use highly effective contraception throughout the study and for ≥1 month after the last dose of tirzepatide

• Age ≥18 years and ≤75 years at the time of screening
• Documented symptomatic paroxysmal AF or persistent AF, confirmed by 12-lead ECG, Holter monitoring, or cardiac monitoring device, with documented AF episode duration ≥7 days (for persistent AF) and total AF history duration ≤5 years
• 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)
• Failed response to or intolerance of at least one antiarrhythmic drug (AAD), or explicit patient preference for a rhythm control strategy
• Undergoing catheter ablation for AF at a participating center, with confirmed successful restoration of sinus rhythm at the end of the procedure (as determined by the operator)
• Willing and able to understand the study procedures, provide written informed consent, and comply with all protocol requirements including 12-month follow-up visits
• Capable of performing basic physical activity (no absolute contraindication to moderate-intensity aerobic exercise)