Atrial FibrillationPhase 4NCT05209165
Semaglutide to Reduce Atrial Fibrillation Burden
A Phase 4 study testing Semaglutide in people with Atrial Fibrillation and Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Obesity, Overweight
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- May 2023to May 2028
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center San Francisco
San Francisco, California, 94121
About this study
Official title: Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden
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
- Being tested
- Semaglutide, Placebo
- Keywords
- weight loss, atrial fibrillation, lifestyle modification
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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
PlaceboDrug
Matching placebo and intake visit for VA MOVE
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (13)
Epicardial adipose tissue
Change in epicardial adipose tissue on non-contrast chest/abdomen CT scans from baseline and week 52
Measured: 52 weeks
Sleep apnea
Change in apnea-hypopnea index from baseline sleep study to sleep study at week 52
Measured: 52 weeks
Left atrial function
The change in LA longitudinal strain from the baseline echocardiogram to the echocardiogram at 52 weeks.
Measured: 52 weeks
Weight change
From baseline to week 52
Measured: 52 weeks
Adherence and Adverse Events
From baseline to week 52
Measured: 52 weeks
Participation in VA MOVE
assess participation
Measured: 52 weeks
Change in AF burden for four weeks
Change in AF burden for 4 weeks before starting the medication to weeks 48-52.
Measured: 52 weeks
Fat depots
change in pericardial, abdominal (visceral and subcutaneous) and hepatic adipose tissue
Measured: 52 weeks
Left atrial size and function
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
Measured: 52 weeks
Quality of life on Healthcare Quality of Life surverys
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
Measured: 52 weeks
Change in C-reactive Protein (CRP)
Change in the biomarker CRP between baseline and week 52
Measured: 52 weeks
Blood pressure
Changes in blood pressure and blood pressure medication use between baseline and week 52 will be assessed at those visits.
Measured: 52 weeks
Change in Interleukin-6 (IL-6)
Change in the biomarker IL- 6 between baseline and week 52
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study startMay 2023 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Adam Oesterle, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209165
- Sponsor's protocol ID
- SFVAEP1
- Status last verified
- Oct 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden
- ClinicalTrials.gov ID
- NCT05209165
- Acronym / sponsor ID
- SFVAEP1
- Conditions
- Atrial Fibrillation, Obesity, Overweight
- Keywords
- weight loss, atrial fibrillation, lifestyle modification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company decision
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Study start
- May 2023 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutideweekly 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 | Drug | Semaglutide |
| PlaceboMatching placebo and intake visit for VA MOVE | Drug | Placebo |
Primary outcome
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.
13 secondary outcomes
Epicardial adipose tissue
Time frame: 52 weeks
Sleep apnea
Time frame: 52 weeks
Left atrial function
Time frame: 52 weeks
Weight change
Time frame: 52 weeks
Adherence and Adverse Events
Time frame: 52 weeks
Participation in VA MOVE
Time frame: 52 weeks
Change in AF burden for four weeks
Time frame: 52 weeks
Fat depots
Time frame: 52 weeks
Left atrial size and function
Time frame: 52 weeks
Quality of life on Healthcare Quality of Life surverys
Time frame: 52 weeks
Change in C-reactive Protein (CRP)
Time frame: 52 weeks
Blood pressure
Time frame: 52 weeks
Change in Interleukin-6 (IL-6)
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Atrial Fibrillation and Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.