Can a diabetes pill help the heart heal after a hole is closed?
NCT ID NCT07823972
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Adults with a secundum atrial septal defect (a hole in the heart) who are scheduled for device closure receive either dapagliflozin or a placebo for six months. Researchers use advanced echocardiography to measure how well the right side of the heart recovers and reverses its enlargement. The trial aims to see if adding dapagliflozin improves heart function beyond closure alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dapagliflozin, a diabetes drug that may help the heart remodel
- What this could lead to
- If it works, dapagliflozin could become a simple pill added after ASD closure to help the right heart recover faster and more completely.
- What could go wrong
- This is a small, single-center study with 70 people. Dapagliflozin may not improve heart recovery after closure, and it can cause side effects like genital infections or dehydration.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assiut university
Asyut, Egypt
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