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Recruiting

NCT Number: NCT07692256

the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

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

Recruiting

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Key information

Conditions

Heart Failure Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams Hospital

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. serum Brain Natriuretic Peptide (BNP) in pg/mL

    Time frame: Day1 and on day 90

Secondary outcomes

  1. Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography

    Time frame: on Day1 and on day 90

  2. and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography

    Time frame: Day1 and on day 90

Study contacts

Contact information is provided by the study sponsor or research team.

nassar elsayed nassar, master candidate

CONTACT

[email protected]

+0021223333236

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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