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the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2025-12-01
Est. completion2026-12-01
Eligibility
Age1 Month – 18 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 1 Month – 18 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseaseHeart Failure

Interventions2

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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