Dapagliflozin and Right Heart Recovery After ASD Device Closure
Impact of Dapagliflozin Therapy on Right Ventricular Remodeling Following Transcatheter Atrial Septal Defect Closure in Adults: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: nada deyaa, master
- Phone Number: 0201060123997
- Email: nada.deyaaa@yahoo.com
Study Locations
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Asyut, Egypt
- Assiut University
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Contact:
- Heba Elnaggar, Associate professor
- Phone Number: 01001963100 01001963100
- Email: heba_m_elnaggar@yahoo.com
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Contact:
- Mohamed Osman, lecturer
- Email: m.osman@aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. 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. 3. Sinus rhythm on presentation.
Exclusion Criteria:
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). 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.
7. 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.
9. Poor-quality Echocardiography images precluding strain analysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: dapagliflozin arm
given dapagliflozin post ASD closure
|
randomized clinical trila
|
|
Placebo Comparator: control
given regular treament post ASD closure
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randomized clinical trila
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RV strain
Time Frame: follow up after 3 and 6 months
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Assess changes in Right Ventricular Free Wall Longitudinal Strain (RVFWLS) using 2D speckle-tracking echocardiography over a 6-month post-procedural period.
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follow up after 3 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohamed abdel ghany koriem, professor, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- not yet submitted
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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