Semaglutide to Reduce Atrial Fibrillation Burden
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05209165|
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : February 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Obesity Overweight||Drug: Semaglutide Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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||
Matching placebo and intake visit for VA MOVE
- 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.
- Epicardial adipose tissue [ Time Frame: 52 weeks ]Change in epicardial adipose tissue on non-contrast chest/abdomen CT scans from baseline and week 52
- Sleep apnea [ Time Frame: 52 weeks ]Change in apnea-hypopnea index from baseline sleep study to sleep study at week 52
- Left atrial function [ Time Frame: 52 weeks ]The change in LA longitudinal strain from the baseline echocardiogram to the echocardiogram at 52 weeks.
- Weight change [ Time Frame: 52 weeks ]From baseline to week 52
- Adherence and Adverse Events [ Time Frame: 52 weeks ]From baseline to week 52
- Participation in VA MOVE [ Time Frame: 52 weeks ]assess participation
- 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.
- Fat depots [ Time Frame: 52 weeks ]change in pericardial, abdominal (visceral and subcutaneous) and hepatic adipose tissue
- 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
- 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
- Change in C-reactive Protein (CRP) [ Time Frame: 52 weeks ]Change in the biomarker CRP between baseline and week 52
- 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.
- Change in Interleukin-6 (IL-6) [ Time Frame: 52 weeks ]Change in the biomarker IL- 6 between baseline and week 52
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
|Contact: Adam Oesterle, MD||4152214810 ext firstname.lastname@example.org|
|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 email@example.com|