RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 7
- 主要终点
- Atrial fibrillation recurrence
研究概览
简要总结
The goal of this clinical trial is to learn if drug dapagliflozin, a sodium-glucose transport-2 inhibitor, works to treat atrial fibrillation in adults. The main question it aims to answer is:
• Does the drug dapagliflozin reduce the recurrence rate of atrial fibrillation?
Researchers will compare drug dapagliflozin to standard therapy to see if drug dapagliflozin reduce the recurrence of atrial fibrillation.
Persons with atrial fibrillation who are planned for an electric cardioversion will:
- Take the drug dapagliflozin, or no drug, once a day for a maximum of 56 days
- Undergo a planned electric cardioversion of the atrial fibrillation
- Record the rhythm with a hand-held device that transmits the signal to researchers during the study period, but no longer than for 56 days
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AF on ECG who are planned for electrical cardioversion within 7-26 days from inclusion-date.
- •Age ≥ 55 years.
- •Provided written informed consent.
排除标准
- •Current treatment with an SGLT2 inhibitor.
- •Prior/current diagnosis of heart failure.
- •Type 1 diabetes mellitus.
- •Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m
- •Pulmonary vein isolation within preceding 3 months or planned pulmonary vein isolation during the study period (56 days).
- •Contraindications to SGLT2 inhibitors.
- •Any condition or circumstance in which the patient should not participate in the study according to the study investigator.
研究组 & 干预措施
Dapagliflozin
Tablet Dapagliflozin 10 mg once daily
干预措施: Dapagliflozin 10 mg once daily (Drug)
结局指标
主要结局
Atrial fibrillation recurrence
时间窗: 30 days after elective electrical cardioversion
Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion.
次要结局
- Proportion of patients in SR at 30 days(30 days after elective electrical cardioversion)
- Proportion of patients without any atrial fibrillation recurrence at 30 days(30 days after elective electrical cardioversion)
- Time to spontaneous return to sinus rhythm before electrical cardioversion(Up to 26 days)
- Spontaneous return to sinus rhythm before cardioversion.(Up to 26 days)
- Success of cardioversion(Periprocedural)
- Total number of days with atrial fibrillation(From day of electric cardioversion to 30 days after)
- Absence of clinical atrial fibrillation recording(From randomization to 30 days after electric cardioversion)