Atrial Fibrillation (AF)
Conditions
Brief summary
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.
Interventions
Catheter ablation for AF plus semaglutide (up to 2.4 mg weekly)
Sponsors
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period) | 12 months |
Outcome results
None listed