the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients

NCT07692256 | Recruiting Phase 2 DMC

• 1 other identifier: RHDIRB2020110301 REC#463
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

heart failure; empagliflozin; dilated cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• serum Brain Natriuretic Peptide (BNP) in pg/mL

  Day1 and on day 90

Secondary Outcomes (2)

• 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

Study Arms (2)

control

ACTIVE COMPARATOR

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

protocol

EXPERIMENTAL

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: Empagliflozin (EMPA); Drug: Standard medical treatment

Interventions

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.

protocol

Standard medical treatment DRUG

ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.

control; protocol

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Hospital

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

nassar elsayed nassar, master candidate

CONTACT

+0021223333236; nassar.mohamed17@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 9, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)