Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in left atrial strain
研究概览
简要总结
Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
- •Patient age 18-60 years.
- •Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
- •Patient with normal left atrium or dilated (diameter <5 cm)
排除标准
- •Patients < 18 yrs old.
- •Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
- •Patients with left atrium > 5cm.
- •Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
- •Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
- •Patient with previous ischemic stroke.
研究组 & 干预措施
Dapagliflozin
patients who will receive SGLT2 inhibitors
干预措施: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor (Drug)
Dapagliflozin
patients who will receive SGLT2 inhibitors
干预措施: Rhythm control and anticoagulation (Drug)
Placebo
Patients who will receive Rhythm control +/- oral anticoagulation
干预措施: Rhythm control and anticoagulation (Drug)
结局指标
主要结局
Changes in left atrial strain
时间窗: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial strain %
Left atrial remodeling
时间窗: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring Indexed LA volume (LAVI) in ml/m2
Changes in left atrial systolic force
时间窗: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial systolic force in ml/m3
次要结局
- Mortality Rate(After the first dose of treatment till the end of the study (1 year))
- Incidence of Hospitalization due to HF(After the first dose of treatment till the end of the study (1 year))
- Mean percentage of time spent in atrial fibrillation(After the first dose of treatment till the end of the study (1 year))
- Number of participants with Stroke(After the first dose of treatment till the end of the study (1 year))
研究者
Aml Soliman
Lecturer of cardiology, Aswan university
Aswan University