Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 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
This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease.
详细描述
Atrial fibrillation (AF) is one of the most common arrhythmias. Catheter ablation of atrial fibrillation, as the main means of rhythm control, can effectively maintain sinus rhythm, reduce the recurrence of AF burden, and improve the patient's quality of life and prognosis. However, AF recurrence still occurs in 30-50% of patients after atrial fibrillation catheter ablation, and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. Several studies demonstrated that SGLT2i might reduce AF/atrial flutter events among patients with diabetes. Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation. However, the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain.
In this study, we aim to evaluate the effect of dapagliflozin on AF burden. Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk, heart failure, or chronic kidney disease will be enrolled. Patients will be randomly assigned to either the dapagliflozin group (10mg/d) for 3 months or the control group stratified according to body mass index (<24, ≥24kg/m2) or left atrial diameter (<45，≥45mm).
The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation. Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months. Our central hypothesis is that SGLT2i will reduce the AF burden after 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
- Single (Outcomes Assessor)
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 between 18-80 years
- •diagnosed with persistent atrial fibrillation based on ECG or Holter
- •planned initial catheter ablation for atrial fibrillation
- •have the capacity to understand and sign an informed consent form.
排除标准
- •diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm
- •diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.)
- •severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.)
- •currently take sodium-glucose co-transporter 2 inhibitors
- •have the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. type 2 diabetes ii. history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. chronic kidney disease with eGFR=20-60 ml/min/1.73m2
- •have the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. previous allergic reactions to dapagliflozin ii. end-stage renal failure or dialysis
- •type 1 diabetes, or previous diabetic ketoacidosis
- •severe hypoglycemia or genitourinary infection in the past 12 months
- •hypovolemia or hypotension
- •planned surgery or other interventional procedure within 3 months
- •other arrhythmias mandating anti-arrhythmic drug therapy
- •have intracardiac thrombus
- •active infection
- •unable to give informed consent
- •women of childbearing potential
- •currently enrolled in another clinical study
- •other condition unsuitable to participate in this study judged by investigators
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 10 mg per day for 3 months after initial catheter ablation (Drug)
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)
- Changes of quality of life at 3 months(3 months)
- Echocardiography changes of left atrial structure at 3 months(3 months)
- Atrial fibrillation recurrence during 1 year after ablation(1 year)
- Cardiovascular outcomes during 1-year follow-up(1 year)