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the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
Sponsor: Ain Shams University
Summary
the study to investigate the efficacy of empagiflozin in pediatric heart failure
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-01
Completion Date
2027-02-01
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin (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.
Standard 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