Empagliflozin for Pediatric Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the safety and potential benefit of empagliflozin in pediatric patients with heart failure who have reduced heart function or other signs of congestion. Participants receive empagliflozin alongside their usual medical treatment and are monitored for changes in heart function and clinical status. The trial includes children from birth up to 18 years old who meet specific heart failure criteria and excludes those with significant kidney impairment or certain contraindications. The study is led by Ain Shams University at Ain Shams Hospital in Cairo.

Why it matters

Who can join: the full rules

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's running

• Ain Shams Hospital
  Cairo, Cairo Governorate, Egypt Recruiting

Study contacts

• Study coordinator: nassar elsayed nassar, master candidate
• Email: nassar.mohamed17@pharma.asu.edu.eg
• Phone: +0021223333236

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.