RecruitingPhase 2NCT07692256

the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients


Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

the study to investigate the efficacy of empagiflozin in pediatric heart failure


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Empagliflozin (EMPA) and a drug called Standard medical treatment for people with heart failure. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Month to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin (EMPA)

It's a randomized open-label two-arm prospective parallel study of 60 pediatric hospitalized patients. experimental Group : 30 patients will receive empagliflozin for 90 days in addition to standard of care. empagliflozin will be administered at a starting dose 0.25-0.5 mg/kg/day (maximum 25 mg per day) enterally once daily using available 10mg and 25mg tablet for at least 30 days to patients already receiving standard HF medical therapy. Assess for glucosuria no sooner than one week after starting empagliflozin with target of 1+to 3+. If negative or trace glucosuria, increase dose to maintain target 0.25-0.5 mg/kg/day (maximum 25 mg once daily). active comparator Group : 30 patients will receive standard of care only which includes ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics.

DRUGStandard medical treatment

ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.


Locations(1)

Ain Shams Hospital

Cairo, Cairo Governorate, Egypt

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NCT07692256


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