Semaglutide to Reduce Atrial Fibrillation Burden

San Francisco Veterans Affairs Medical Center

Status and phase: Suspended; Phase 4

Conditions: Overweight; Atrial Fibrillation; Obesity

Treatments: Drug: Placebo; Drug: Semaglutide

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05209165

SFVAEP1

Details and patient eligibility

About

Atrial fibrillation (AF) is the most common arrhythmia worldwide. AF is associated with obesity and the co-morbidities of obesity, including hypertension and obstructive sleep apnea (OSA) which increase left atrial (LA) size and decrease LA function. Semaglutide, a Glucagon-like peptide receptor 1 agonist (GLP-1 RA), is currently approved by the Food and Drug Administration for weight loss for individuals with and without diabetes. The effects of pharmacologic weight loss with Semaglutide on AF are unknown. The investigators plan on conducting a randomized controlled trial of semaglutide versus placebo in individuals with paroxysmal or early persistent AF (>10% AF burden on ambulatory monitoring, a previous electrical cardioversion, or AF lasting ≥ 7 days but < 3 months who have a body mass index ≥ 27.0 kg/m2. The trial will last for 52 weeks. The primary outcome will be the change in AF burden for 2 weeks, immediately before starting the medication or placebo to two weeks starting at week 50, as determined by an implantable loop recorder or two week ambulatory Additional outcomes will be change in epicardial adipose tissue as determined by chest/abdomen/pelvis computed tomography scan at enrollment and at week 52, change in apnea-hypopnea index from baseline sleep study to week 52 sleep study, change in LA longitudinal strain from baseline echocardiogram to echocardiogram at 52 weeks, and change on symptom surveys.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years old with a BMI ≥ 27 kg/m2 who have paroxysmal AF with a ≥ 10% burden on ambulatory monitoring or a previous electrical cardioversion or early persistent AF (≥ 7 days, < 3 months) who are willing to attempt rhythm control.

Exclusion criteria

• Unable to consent
• A personal or family history of medullary thyroid carcinoma
• A personal or family history of multiple endocrine neoplasia syndrome type 2
• History of allergic reaction to Semaglutide or any of its components
• Currently pregnant or planning to become pregnant
• Currently breastfeeding
• History of acute pancreatitis
• History of pancreatic adenocarcinoma
• Previous or current GLP-1 RA use
• Previous or current use of alternative pharmacologic weight loss agents (phentermine, diethylpropion, orlistat, phentermine-topiramate, bupropion- naltrexone, gelesis100, or setmelanotide)
• Unable to tolerate anticoagulation
• History of bariatric surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

132 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Treatment:

Drug: Semaglutide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo