the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

Conditions

Empagliflozin (EMPA) — DRUG
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 — DRUG
ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.

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

Active Comparator: control
30 patients will receive standard of care only which includes ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.
Experimental: protocol
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). for patients who cannot swallow tablet, tablet of 10mg will be crushed and mixed with 10 ml of water to make concentration of 1mg/1ml and calculated dose given from this solution

serum Brain Natriuretic Peptide (BNP) in pg/mL [ Time Frame: Day1 and on day 90 ]

Nationwide