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the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07692256
Enrollment
60
Registered
2026-07-09
Start date
2025-12-01
Completion date
2027-02-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, empagliflozin, dilated cardiomyopathy

Brief summary

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

Interventions

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
serum Brain Natriuretic Peptide (BNP) in pg/mLDay1 and on day 90

Secondary

MeasureTime frame
Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiographyon Day1 and on day 90
and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiographyDay1 and on day 90

Countries

Egypt

Contacts

CONTACTnassar elsayed nassar, master candidate
nassar.mohamed17@pharma.asu.edu.eg+0021223333236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026