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Heart failure hope for kids: diabetes drug tested as new therapy

NCT ID NCT07692256

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether empagliflozin, a drug originally used for diabetes, can help children with heart failure. About 60 children aged 1 month to 18 years with confirmed heart failure will receive either standard care plus empagliflozin or standard care alone for 90 days. Researchers will measure changes in heart function and blood markers of heart strain to see if the drug offers additional benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin
What this could lead to
If it works, this could point toward a new treatment option for children with heart failure, potentially improving heart function and reducing symptoms.
What could go wrong
This is a small, early-phase study with only 60 children, so results may not apply to all pediatric heart failure patients. Empagliflozin can cause side effects like dehydration or urinary tract infections.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Started

Dec 2025

Expected to finish

Feb 2027

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

1 month to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * • Pediatrics (aged 1months-18 years) * Confirmed HF diagnosis: HF will be defined by reduced ventricular systolic function (left ventricular ejection fraction by echocardiography) or impaired ventricular filling (pulmonary capillary wedge pressure \> 18 mmHg measured directly and/or the ratio of early diastolic mitral inflow velocity(E) to early diastolic mitral annular velocity (e')( E/e'\>14 by echocardiography) with clinical features of congestion and/or low cardiac output. • Class III or IV of ROSS classification or BNP level more than 300 pg/mL Exclusion Criteria: * • Pediatric with chronic kidney failure * Avoid initiating empagliflozin in patients with concurrent urinary tract infection (UTI). * patients with eGFR \<60 mL/minute/1.73 m2 will be excluded. * Patients with contraindication to empagliflozin usage which include * eGFR \<30 mL/minute/1.73 m2 * Hypersensitivity (eg, angioedema) to empagliflozin

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Conditions

The condition(s) this trial relates to.

dilated cardiomyopathy heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. 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

  • Ain Shams Hospital

    RECRUITING

    Cairo, Cairo Governorate, Egypt

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