Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Atrial fibrillation burden
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Semaglutide
干预措施: Semaglutide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Atrial fibrillation burden
时间窗: 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.
次要结局
- Quality of life on Healthcare Quality of Life surverys(52 weeks)
- Participation in VA MOVE(52 weeks)
- Left atrial size and function(52 weeks)
- Sleep apnea(52 weeks)
- Fat depots(52 weeks)
- Weight change(52 weeks)
- Adherence and Adverse Events(52 weeks)
- Change in Interleukin-6 (IL-6)(52 weeks)
- Epicardial adipose tissue(52 weeks)
- Left atrial function(52 weeks)
- Change in AF burden for four weeks(52 weeks)
- Change in C-reactive Protein (CRP)(52 weeks)
- Blood pressure(52 weeks)
研究者
Adam Oesterle
Principal Investigator
San Francisco Veterans Affairs Medical Center