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Semaglutide to Reduce Atrial Fibrillation Burden

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ClinicalTrials.gov Identifier: NCT05209165
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Adam Oesterle, San Francisco Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Obesity Overweight Drug: Semaglutide Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide Drug: Semaglutide
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

Placebo Comparator: Placebo Drug: Placebo
Matching placebo and intake visit for VA MOVE




Primary Outcome Measures :
  1. Atrial fibrillation burden [ Time Frame: 52 weeks ]
    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.


Secondary Outcome Measures :
  1. Epicardial adipose tissue [ Time Frame: 52 weeks ]
    Change in epicardial adipose tissue on non-contrast chest/abdomen CT scans from baseline and week 52

  2. Sleep apnea [ Time Frame: 52 weeks ]
    Change in apnea-hypopnea index from baseline sleep study to sleep study at week 52

  3. Left atrial function [ Time Frame: 52 weeks ]
    The change in LA longitudinal strain from the baseline echocardiogram to the echocardiogram at 52 weeks.

  4. Weight change [ Time Frame: 52 weeks ]
    From baseline to week 52

  5. Adherence and Adverse Events [ Time Frame: 52 weeks ]
    From baseline to week 52

  6. Participation in VA MOVE [ Time Frame: 52 weeks ]
    assess participation

  7. Change in AF burden for four weeks [ Time Frame: 52 weeks ]
    Change in AF burden for 4 weeks before starting the medication to weeks 48-52.

  8. Fat depots [ Time Frame: 52 weeks ]
    change in pericardial, abdominal (visceral and subcutaneous) and hepatic adipose tissue

  9. Left atrial size and function [ Time Frame: 52 weeks ]
    Changes in LA size and function between baseline and week 52 echocardiograms: LA volume as assessed using the biplane disk summation method, LA reservoir strain, LA conduit strain, and LA booster pump strain will be assessed as secondary outcomes

  10. Quality of life on Healthcare Quality of Life surverys [ Time Frame: 52 weeks ]
    Quality of life on the Short-Form 36 survey and the AF symptoms and severity checklist, which will be completed at baseline and at week 52

  11. Change in C-reactive Protein (CRP) [ Time Frame: 52 weeks ]
    Change in the biomarker CRP between baseline and week 52

  12. Blood pressure [ Time Frame: 52 weeks ]
    Changes in blood pressure and blood pressure medication use between baseline and week 52 will be assessed at those visits.

  13. Change in Interleukin-6 (IL-6) [ Time Frame: 52 weeks ]
    Change in the biomarker IL- 6 between baseline and week 52



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209165


Contacts
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Contact: Adam Oesterle, MD 4152214810 ext 24365 adam.oesterle@va.gov

Locations
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United States, California
Veterans Affairs Medical Center San Francisco
San Francisco, California, United States, 94121
Contact: Adam Oesterle, M.D.    415-221-4810 ext 24365    adam.oesterle@va.gov   
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
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Responsible Party: Adam Oesterle, Principal Investigator, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT05209165    
Other Study ID Numbers: SFVAEP1
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Oesterle, San Francisco Veterans Affairs Medical Center:
weight loss
atrial fibrillation
lifestyle modification
Additional relevant MeSH terms:
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Atrial Fibrillation
Overweight
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Body Weight