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Can a diabetes pill help the heart heal after a hole is closed?

NCT ID NCT07823972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Assiut university

    Asyut, Egypt

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Other studies related to the condition(s) this trial covers.