Dapagliflozin and Right Heart Recovery After 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.

• 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.
• 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.

• 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.

Inclusion criteria

• 1. Adults with ASD and significant left to right shunt which is anatomically suitable for transcatheter device closure.

• Adults (age ≥18 years) of both genders. 3. Sinus rhythm on presentation.

Exclusion criteria

• 1. Presence of other congenital anomalies e.g. AV canal, CoA, VSDs, PDA, dextrocardia.

• Significant irreversible pulmonary hypertension (PVR ≥ 5 wood units) or Eisenmenger syndrome.

• Patients presented with arrythmias (especially atrial fibrillation). 4. Severe left ventricular systolic dysfunction (LV ejection fraction (< 50%). 5. Significant Valvular Heart Disease. 6. Patients known to have history of ischemic heart disease or percutaneous coronary interventions.

• Severely impaired renal function defined as an estimated glomerular filtration rate (eGFR) (< 30 mL/min/1.73m²) 8. 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.

• Poor-quality Echocardiography images precluding strain analysis