Clinical trial NCT05209165: Semaglutide to Reduce Atrial Fibrillation Burden
Official title: Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Atrial Fibrillation
Obesity
Overweight
Keywords: weight loss
atrial fibrillation
lifestyle modification
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2022-01-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation burden
timeFrame: 52 weeks
Secondary outcomes:
measure: Epicardial adipose tissue
timeFrame: 52 weeks
measure: Sleep apnea
timeFrame: 52 weeks
measure: Left atrial function
timeFrame: 52 weeks
measure: Weight change
timeFrame: 52 weeks
measure: Adherence and Adverse Events
timeFrame: 52 weeks
measure: Participation in VA MOVE
timeFrame: 52 weeks
measure: Change in AF burden for four weeks
timeFrame: 52 weeks
measure: Fat depots
timeFrame: 52 weeks
measure: Left atrial size and function
timeFrame: 52 weeks
measure: Quality of life on Healthcare Quality of Life surverys
timeFrame: 52 weeks
measure: Change in C-reactive Protein (CRP)
timeFrame: 52 weeks
measure: Blood pressure
timeFrame: 52 weeks
measure: Change in Interleukin-6 (IL-6)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center San Francisco
state: California
Study officials:
References: