the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin (EMPA), Standard medical treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
the study to investigate the efficacy of empagiflozin in pediatric heart failure
Interventions
- 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 star - Drug Standard medical treatment
ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand.
Primary outcome measures
- serum Brain Natriuretic Peptide (BNP) in pg/mL [Time frame: Day1 and on day 90]
Secondary outcome measures (2)
- Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography [Time frame: on Day1 and on day 90]
- and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography [Time frame: Day1 and on day 90]
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 <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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams Hospital — Cairo
Identifiers
NCT: NCT07692256 · RHDIRB2020110301 REC#463