the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
Recruiting · NCT07692256 · Interventional (participants receive a specific treatment) · Lead sponsor: Ain Shams University
View the official record on ClinicalTrials.gov →Interventions studied
Empagliflozin (EMPA)Standard medical treatment
What this trial is about
the study to investigate the efficacy of empagiflozin in pediatric heart failure
Who can take part
Age range
1 Month to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Ain Shams Hospital - Cairo, Cairo Governorate, Egypt