Impact of Dapagliflozin Therapy on Right Ventricular Remodeling Following Transcatheter Atrial Septal Defect Closure in Adults: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- RV strain
研究概览
简要总结
The aim of this study is to evaluate the clinical and echocardiographic influence of dapagliflozin on right ventricular reverse remodeling in adult patients following successful transcatheter Atrial Septal Defect (ASD) device closure.
详细描述
All patients will be subjected to:
A. Detailed medical history review, clinical evaluation, 12- lead ECG before intervention.
B. Full Laboratory investigations: Preoperative standard Lab Screening: CBC, liver function tests (ALT, AST), coagulation profile, HbA1c, serum creatinine and blood urea nitrogen. The estimated glomerular filtration rate (eGFR) will be calculated using the MDRD or CKD-EPI formula to confirm compliance with the inclusion threshold (≥ 30 mL/min/1.73m²).
C. Echocardiography (TTE):
- ASD size, anatomy and direction of shunting (better assessment using TEE if available), Screening for other congenital anomalies.
- RV dimensions: basal and mid-cavity RV dimensions are measured in RV focused apical view.
- RV function: by measurement of tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC) and tricuspid systolic (S') peak velocity by Tissue Doppler Imaging (TDI), were made according to the guidelines . RVFAC is considered normal when > 35%. TAPSE is considered normal when > 16 mm. S' with a value below 10 cm/s suggesting systolic dysfunction.
- Tricuspid regurgitation severity, calculation of RVSP from TR velocity.
- LV dimensions and volumes.
- LV systolic function using Simpson's method.
- LV diastolic function.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with ASD and significant left to right shunt which is anatomically suitable for transcatheter device closure.
- •2. Adults (age ≥18 years) of both genders.
- •Sinus rhythm on presentation.
排除标准
- •1. Presence of other congenital anomalies e.g. AV canal, CoA, VSDs, PDA, dextrocardia.
- •2. Significant irreversible pulmonary hypertension (PVR ≥ 5 wood units) or Eisenmenger syndrome.
- •3. Patients presented with arrythmias (especially atrial fibrillation).
- •Severe left ventricular systolic dysfunction (LV ejection fraction (< 50%).
- •Significant Valvular Heart Disease.
- •Patients known to have history of ischemic heart disease or percutaneous coronary interventions.
- •7. Severely impaired renal function defined as an estimated glomerular filtration rate (eGFR) (< 30 mL/min/1.73m²)
- •Patients with contraindications for SGLT2i: Type 1 diabetes mellitus, history of diabetic ketoacidosis, recurrent severe urinary tract infections, active genital mycotic infections, or known hypersensitivity to dapagliflozin.
- •9. Poor-quality Echocardiography images precluding strain analysis
研究组 & 干预措施
dapagliflozin arm
given dapagliflozin post ASD closure
干预措施: trans catheter device closure (Device)
control
given regular treament post ASD closure
干预措施: trans catheter device closure (Device)
结局指标
主要结局
RV strain
时间窗: follow up after 3 and 6 months
Assess changes in Right Ventricular Free Wall Longitudinal Strain (RVFWLS) using 2D speckle-tracking echocardiography over a 6-month post-procedural period.
次要结局
未报告次要终点
研究者
Nada Deyaa
Assiut university
Assiut University