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

University of Luebeck

Status and phase

Begins enrollment in 7 months

Phase 4

Conditions

Atrial Fibrillation (AF)

Treatments

Drug: Semaglutide (SEMA)

Study type

Interventional

Funder types

Other

Identifiers

NCT07389941

SPICE_AF

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-80 years
Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation
BMI ≥30 kg/m or BMI ≥28 kg/m plus ≥1 weight-related comorbidity
No prior treatment with GLP-1 receptor agonists

Exclusion criteria

Current use of GLP-1 or DPP4 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 TIA <30 days prior to screening
Pulmonary embolism <90 days before screening
Myocardial infarction, or stroke <90 days prior to screening
Uncontrolled thyroid disease: TSH >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