Semaglutide to Reduce Atrial Fibrillation Burden

NCT05209165 | Suspended Phase 4 FDA Drug

• 1 other identifier: SFVAEP1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Obesity; Overweight

Keywords

weight loss; atrial fibrillation; lifestyle modification

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden

  Change in AF burden from the two weeks before starting Semaglutide or placebo to the last two weeks of therapy (starting at week 50). AF burden will be assessed as percent of time in AF for two weeks on an implantable loop recorder. If the patient declines implantable loop recorder placement, an ambulatory 2-week monitor will be used instead.

  52 weeks

Secondary Outcomes (13)

• Epicardial adipose tissue

  52 weeks

• Sleep apnea

  52 weeks

• Left atrial function

  52 weeks

• Weight change

  52 weeks

• Adherence and Adverse Events

  52 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Semaglutide DRUG

weekly Semaglutide (increased from starting dose of 0.25 mg at four-week intervals (0.5 mg, 1.0 mg, 1.7 mg) to a target dose of 2.4 mg) for 52 weeks with intake visit for the VA MOVE program

Semaglutide

Placebo DRUG

Matching placebo and intake visit for VA MOVE

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead

Study Sites (1)

Veterans Affairs Medical Center San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Obesity; Overweight; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 26, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)