NCT07389941尚未招募4 期
Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation (SPICE-AF)
University of Luebeck0 个研究点目标入组 240 人开始时间: 2026年10月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)
研究概览
简要总结
To evaluate whether pre-treatment with semaglutide is superior to standard care in improving freedom from atrial fibrillation (AF) at 12 months following catheter ablation in patients with obesity and symptomatic AF undergoing first-time ablation.
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
- Single (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
- •Age 18-80 years
- •Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation
- •Body mass index ≥30 kg/m or body mass index ≥28 kg/m plus ≥1 weight-related comorbidity
- •No prior treatment with glucacon-like peptide-1 receptor agonists
排除标准
- •Current use of glucacon-like peptide-1 receptor agonists or dipeptidyl peptidase 4 inhibitors or use within the last 90 days prior to screening
- •Current antiobesity medication use or use within the last 90 days prior to screening
- •A self-reported change in body weight of >5 kg within 30 days before screening
- •History of bariatric surgery
- •History of diabetes mellitus
- •Hospitalization for unstable angina, or transient ischemic attack <30 days prior to screening
- •Pulmonary embolism <90 days before screening
- •Myocardial infarction, or stroke <90 days prior to screening
- •Uncontrolled thyroid disease: thyroid-stimulating hormone >10.0 mIU/L or <0.4 mIU/L at screening
- •Active malignancy
- •Acute pancreatitis <180 days before screening
- •History or presence of chronic pancreatitis
- •Chronic kidney disease with creatinine clearance <30 mL/min
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids
- •Pregnancy, breast-feeding or planning pregnancy
研究组 & 干预措施
Catheter ablation for atrial fibrillation plus semaglutide
Experimental
Catheter ablation for atrial fibrillation plus semaglutide (up to 2.4 mg weekly)
干预措施: Semaglutide (SEMA) (Drug)
Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy
No Intervention
Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy (standard therapy)
结局指标
主要结局
Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Roland Richard Tilz, MD
Director, Department of Rhythmology
University of Luebeck
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