ASD2(Secundum Atrial Septal Defect)NCT07823972
Dapagliflozin and Right Heart Recovery After ASD Device Closure
A study testing trans catheter device closure in people with ASD2(Secundum Atrial Septal Defect), run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ASD2(Secundum Atrial Septal Defect)
- What is being tested?
- trans catheter device closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 30 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut
Heba Elnaggar, Associate professor, 01001963100 ext. 01001963100, heba_m_elnaggar@yahoo.com
Mohamed Osman, lecturer, m.osman@aun.edu.eg
About this study
Official title: Impact of Dapagliflozin Therapy on Right Ventricular Remodeling Following Transcatheter Atrial Septal Defect Closure in Adults: Randomized Clinical Trial
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.
Read the detailed description
All patients will be subjected to:
- Detailed medical history review, clinical evaluation, 12- lead ECG before intervention.
- 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).
- 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.
- 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
- 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
- Left Atrial Strain tracking will be conducted on standard, non-foreshortened apical 4-chamber and 2-chamber cine loops optimizing the LA boundaries. [12]
- 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
- 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)
- 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.
- 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):
- 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).
- Control Group: Patients will receive standard post-closure medical therapy alone. The total planned duration of active pharmacological follow-up is 6 months
- 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
- ASD2(Secundum Atrial Septal Defect)
- Being tested
- trans catheter device closure
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans catheter device closureDevice
randomized clinical trila
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin arm | Active comparator | given dapagliflozin post ASD closure Receives: Device: trans catheter device closure |
| control | Placebo comparator | given regular treament post ASD closure Receives: Device: trans catheter device closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
RV strain
Assess changes in Right Ventricular Free Wall Longitudinal Strain (RVFWLS) using 2D speckle-tracking echocardiography over a 6-month post-procedural period.
Measured: follow up after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASD2(Secundum Atrial Septal Defect)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Deyaa, Assiut University
- Investigators
- mohamed abdel ghany koriem, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823972
- Sponsor's protocol ID
- not yet submitted
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided