Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation - A Randomized Open-Label Phase III Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Freedom from all atrial tachyarrhythmias (AF/AFL/AT)
研究概览
简要总结
The goal of this clinical trial is to test the effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation. The main questions it aims to answer are:
• If Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias [atrial fibrillation (AF), atrial flutter (AFL) and atrial tachycardia (AT)] greater than 30 seconds during one-year follow-up after catheter ablation.
Participants will receive Dapagliflozin (FORXIGA) 10 milligram (mg) once a day (QD) for 3 months after catheter ablation of atrial fibrillation. Researchers will compare patients who receive usual care to see if Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias (AF/AFL/AT) during one-year follow-up after catheter ablation.
详细描述
This trial is the third phase of random allocation and non-blind trial. It is divided into study group and control group. The study group is Dapagliflozin therapy, and the treatment period is three months post catheter ablation. The control group is usual care (without Dapagliflozin). The follow-up observation period will be one year after catheter ablation. This trial was performed at Kaohsiung Chang Gung Memorial Hospital and Chang Gung Memorial Hospital, Linkou, and Chiayi branches, and it is a multi-center trial. The study flow chart is as follows.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give written informed consent
- •Men and women age >= 20 years.
- •Paroxysmal, persistent or long-standing persistent atrial fibrillation
- •eGFR >= 25 ml/min/1.73 m2
排除标准
- •Receiving therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor prior to randomization, or intolerance to an SGLT2 inhibitor.
- •Type 1 diabetes mellitus
- •Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or Coronary artery bypass grafting), ablation of atrial flutter/fibrillation, ischemic stroke, and transient ischemic attack within 12 weeks prior to randomization
- •Active malignancy
- •Women of child-bearing potential who have a positive pregnancy test at randomization or who are breast-feeding
- •A life expectancy of fewer than 2 years due to any non-cardiovascular condition, based on the investigator's clinical judgment
- •Expected surgery for structural heart disease, and secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism)
研究组 & 干预措施
Dapagliflozin
Dapagliflozin (FORXIGA) 10 mg QD for 3 months
干预措施: Dapagliflozin 10 mg [Farxiga] (Drug)
结局指标
主要结局
Freedom from all atrial tachyarrhythmias (AF/AFL/AT)
时间窗: 3,6 and 12 months after ablation
Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter test at 3, 6, and 12-month follow-up) and 12-lead electrocardiogram (ECG) performed at cardiovascular (CV) outpatient department (OPD) follow-up within one-year post catheter ablation. (unit: %)
次要结局
- Freedom from all atrial tachyarrhythmias (AF/AFL/AT) excluding the 3-month blanking period(6 and12 months after ablation)
- Freedom from all atrial tachyarrhythmias (AF/AFL/AT) within 3-month blanking period(3 months after ablation)
- Total mortality or hospitalization due to CV cause(12 months after ablation)
- Left atrial (LA) size (LA dimension and LA volume index) by echocardiography(6 and 12 months)
- AF quality of life (QOL) by AF Effect On Quality-Of-Life (AFEQT) questionnaire score(1,3,6,9 and 12 months)
- N-terminal pro-brain natriuretic peptide (NT-proBNP) level(3 and 12 months)
- Glycated Hemoglobin (HBA1c)(3 and 12 months)
- Urine albumin/Cr ratio level(3 and 12 months)
- Repeated catheter ablation or cardioversion for atrial tachyarrhythmia(12 months)
- Creatinine (Cr) and estimated Glomerular filtration rate (eGFR)(3 and 12 months)
- Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration(12 months)
- AF burden(3,6 and 12 months)