2024-513719-28-00招募中4 期
RECURrence of Atrial Fibrillation after cardioversion of patients randomized to open-label treatment with dapagliflozin or usual care (RECUR-AF)
Karolinska University Hospital7 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2024年8月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 7
- 主要终点
- Time to recurrence of AF within 30 days after cardioversion.
研究概览
简要总结
The main objective is to evaluate whether treatment with dapagliflozin, compared to usual care, prolongs the time to atrial fibrillation recurrence within 30 days after cardioversion.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 from inclusion-date.
- •Age ≥ 55 years.
- •The subject has given their written consent to participate in the trial.
排除标准
- •Current treatment with SGLT2 inhibitor (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin).
- •Prior/current diagnosis of heart failure.
- •Type 1 diabetes mellitus.
- •Estimated glomerular filtration rate (eGFR) < 25 ml/min/1.73m
- •Pulmonary vein isolation within last 3 months or planned pulmonary vein isolation within study period (56 days).
- •Contraindications to SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin).
- •Any condition or circumstance in which the patient should not participate in the study according to the study investigator.
结局指标
主要结局
Time to recurrence of AF within 30 days after cardioversion.
Time to recurrence of AF within 30 days after cardioversion.
次要结局
- Success of cardioversion (discharged with SR).
- Spontaneous return to SR before cardioversion.
- Proportion of patients in sinus rhythm (SR) 30 days after cardioversion.
- Proportion of patients without any AF recurrence at 30 days
- Time to spontaneous return to SR before electrical cardioversion.
- Total number of days with AF recordings during 30 days following cardioversion.
- Absence of clinical AF recurrence (12- lead ECG-verified) during follow-up after EC or after spontaneous return to SR (before EC).
研究者
Tema Hjärta-Kärl och Neuro, ME kardiologi
Scientific
Karolinska University Hospital
研究点 (7)
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