the study to investigate the efficacy of empagiflozin in pediatric heart failure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.
Ain Shams Hospital
Cairo, Cairo Governorate, Egypt
RECRUITINGserum Brain Natriuretic Peptide (BNP) in pg/mL
Time frame: Day1 and on day 90
Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography
Time frame: on Day1 and on day 90
and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography
Time frame: Day1 and on day 90
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