Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation (SPICE-AF)

To evaluate whether pre-treatment with semaglutide is superior to standard care in improving freedom from atrial fibrillation (AF) at 12 months following catheter ablation in patients with obesity and symptomatic AF undergoing first-time ablation.

Inclusion criteria:

• Age 18-80 years
• Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation
• Body mass index ≥30 kg/m or body mass index ≥28 kg/m plus ≥1 weight-related comorbidity
• No prior treatment with glucacon-like peptide-1 receptor agonists

Exclusion criteria:

• Current use of glucacon-like peptide-1 receptor agonists or dipeptidyl peptidase 4 inhibitors or use within the last 90 days prior to screening
• Current antiobesity medication use or use within the last 90 days prior to screening
• A self-reported change in body weight of >5 kg within 30 days before screening
• History of bariatric surgery
• History of diabetes mellitus
• Hospitalization for unstable angina, or transient ischemic attack <30 days prior to screening
• Pulmonary embolism <90 days before screening
• Myocardial infarction, or stroke <90 days prior to screening
• Uncontrolled thyroid disease: thyroid-stimulating hormone >10.0 mIU/L or <0.4 mIU/L at screening
• Active malignancy
• Acute pancreatitis <180 days before screening
• History or presence of chronic pancreatitis
• Chronic kidney disease with creatinine clearance <30 mL/min
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids
• Pregnancy, breast-feeding or planning pregnancy