Dapagliflozin and Right Heart Recovery After ASD Device Closure

Overview

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.

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. D. 2D Speckle Tracking Echocardiography ( 2D STE): \- electrocardiographic - gated acquisition of 3- beat loops for standard echocardiographic views, including apical 4 chamber view, apical 2 chamber view, apical 3 chamber view and RV-focused apical 4 chamber view, all obtained in a frame rate between 60- 90 fps \[12\] for offline analysis. 1. Right Ventricular (RV) Strain Analysis o Right Ventricular Free Wall Longitudinal Strain (RVFWLS) will be calculated using a dedicated, non-foreshortened RV-focused apical 4-chamber view. 2. Left Ventricular (LV) Strain Analysis o Left Ventricular Global Longitudinal Strain (LVGLS) will be calculated using standard apical 4-chamber, 2-chamber, and 3-chamber views to derive a complete 17-segment peak systolic strain assessment. 3. Left Atrial (LA) Strain Analysis o Left Atrial Strain tracking will be conducted on standard, non-foreshortened apical 4-chamber and 2-chamber cine loops optimizing the LA boundaries. \[12\] o Phasic Parameter Extraction: Three distinct phasic strain components will be exported from the generated software strain curves: LA Reservoir Strain, LA Conduit Strain, LA Contraction Strain E. Functional capacity assessment: \- All patients will be classified according to NYHA classification and will undergo 6-Minute Walk Test (6MWT) will evaluate functional distance 12\]. also will be evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ) F. Intra- procedural assessment: In the catheterization laboratory, ASD closure will be performed under general anesthesia guided by TEE to assess the following: ASD anatomy and size, Mitral and tricuspid regurgitation and its degree, Hemodynamics study, assessment of device size, type of the device. G. Randomization and treatment allocation - Following successful transcatheter closure and stabilization (typically 24-48 hours post-procedure), eligible patients will be randomized in a 1:1 ratio into one of two parallel groups using a manual allocation, sequentially numbered, opaque, sealed envelopes (SNOSE): o Intervention Group (Dapagliflozin): Patients will receive oral Dapagliflozin 10 mg once daily in addition to standard post-closure medical care (e.g., antibiotics, dual antiplatelet therapy and anti-failure treatment if indicated). o Control Group: Patients will receive standard post-closure medical therapy alone. The total planned duration of active pharmacological follow-up is 6 months H. Follow up of the cases after 3 and 6 months': All patient with be subjected to the following: \- The functional capacity assessment with the same methods: NYHA Class, 6 WMT distance, KCCQ. * Transthoracic Echocardiography with the same measurements which assessed before closure. * 2D Speckle Tracking Echocardiography with the same measurements which assessed before closure.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts