the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Standard medical treatment; Drug: Empagliflozin (EMPA)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: nassar elsayed nassar, master candidate; Phone Number: +0021223333236; Email: nassar.mohamed17@pharma.asu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Recruiting
      • Ain Shams Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Standard medical treatment; 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	Drug: Standard medical treatment; ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.; Drug: Empagliflozin (EMPA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum Brain Natriuretic Peptide (BNP) in pg/mL	Day1 and on day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography	on Day1 and on day 90
and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography	Day1 and on day 90

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: heart failure; dilated cardiomyopathy; empagliflozin
• Additional Relevant MeSH Terms: Laminopathies; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Cardiomyopathies; Cardiomegaly; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Failure; Cardiomyopathy, Dilated; empagliflozin
• Other Study ID Numbers: RHDIRB2020110301 REC#463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No