Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Adam Oesterle

Description

Summary

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.

Official Title

Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden

Keywords

Atrial Fibrillation Obesity Overweight weight loss lifestyle modification Semaglutide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

  • Veterans Affairs Medical Center San Francisco
    San Francisco California 94121 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
San Francisco Veterans Affairs Medical Center
ID
NCT05209165
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated