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Recruiting
NCT07692256
the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
Conditions: Heart Failure
Sex: All
Ages: 1 Month – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Ain Shams University
Location: Ain Shams Hospital Cairo Cairo Governorate
Summary
the study to investigate the efficacy of empagiflozin in pediatric heart failure
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07692256). StuddyBuddy aggregates publicly available trial information.