Efficacy of Dapagliflozin on Catheter Ablation Outcomes in Persistent Atrial Fibrillation Patients With Increased Epicardial Adipose Tissue
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Atrial fibrillation burden at 3 months after ablation
研究概览
简要总结
Persistent atrial fibrillation (PeAF) is associated with a high risk of recurrence following catheter ablation despite advances in ablation technology and strategies. Beyond electrophysiological mechanisms, increasing evidence suggests that atrial structural and inflammatory remodeling plays a pivotal role in the initiation and maintenance of AF, particularly in persistent forms.
Epicardial adipose tissue (EAT) is a metabolically active visceral fat depot located between the myocardium and visceral pericardium. EAT shares a common microcirculation with the underlying atrial myocardium and exerts paracrine and vasocrine effects through the secretion of pro-inflammatory cytokines, adipokines, and profibrotic mediators. Increased EAT volume or thickness has been consistently associated with AF burden, atrial fibrosis, left atrial enlargement, and a higher risk of AF recurrence after catheter ablation.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have demonstrated pleiotropic cardiovascular benefits beyond glucose lowering, including reduction in visceral adiposity, attenuation of systemic and local inflammation, and favorable effects on cardiac remodeling. Observational studies and randomized trials in patients with diabetes or heart failure suggest that SGLT2i therapy reduces incident AF and AF recurrence after ablation. However, the effect of SGLT2i in non-diabetic, non-heart failure patients-particularly those with increased EAT as a distinct pathophysiological substrate-remains unclear.This trial is designed to evaluate whether dapagliflozin, administered peri-ablation, can reduce atrial arrhythmia recurrence in PeAF patients with increased EAT but without class I indications for SGLT2i. This targeted approach aims to provide mechanistic and clinical evidence supporting metabolic-inflammatory modulation as an adjunctive strategy to catheter 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years;
- •Diagnosis of persistent atrial fibrillation (continuous AF >7 days and ≤5 years);
- •Planned first-time catheter ablation for AF;
- •No class I indications for dapagliflozin, defined as:
- •No diabetes mellitus;
- •No history of heart failure (HFrEF, HFmrEF, or HFpEF);
- •No chronic kidney disease (eGFR ≥60 mL/min/1.73 m²);
- •Evidence of increased epicardial adipose tissue on cardiac CT or cardiac MRI, defined according to pre-specified imaging thresholds;
- •Ability to provide written informed consent.
排除标准
- •Duration of persistent AF >5 years;
- •Left atrial anteroposterior diameter >50 mm on transthoracic echocardiography;
- •Prior AF catheter ablation or surgical ablation;
- •Current or recent (within 3 months) use of any SGLT2 inhibitor;
- •Severe structural heart disease (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy);
- •Contraindications to catheter ablation (e.g., left atrial thrombus, active infection);
- •Estimated glomerular filtration rate <60 mL/min/1.73 m²;
- •Type 1 diabetes or history of diabetic ketoacidosis;
- •Pregnancy or breastfeeding;
- •Any condition deemed by investigators to make study participation inappropriate.
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
干预措施: Dapagliflozin (10Mg Tab) along with standard medical therapy (Drug)
Control
结局指标
主要结局
Atrial fibrillation burden at 3 months after ablation
时间窗: 3 months
Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.
次要结局
- Atrial fibrillation recurrence during 3 months after ablation(3 months)
- Atrial fibrillation recurrence during 1 year after ablation(1 year)
- Changes of quality of life at 3 months(3 months)
研究者
Xu Liu
professor
Shanghai Chest Hospital