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Clinical Trials in Italy / NCT06898320
Recruiting Observational

Cardiac Injury Due to Anthracycline in Paediatric Oncological Patients

NCT06898320 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Burlo Garofolo
Phase
Observational
Started
2023-07-21
Last updated
2025-05-09

Condition(s) studied

Heart InjuriesAnthracycline

Study summary

The study investigates the role of echocardiography and of serum biomarkers (NT-proBNP, cardiac Troponin-I) in predicting cardiac injury in a cohort of paediatric oncological patients treated with Anthracycline chemotherapy.

Eligibility

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Paediatric oncological patients 0-18 years * Planned start of anthracycline therapy * Normal left ventricular systolic function according to International Guidelines before the treatment with AC Exclusion Criteria: * Previous anthracycline treatment, bone marrow transplantation or chest radiation * Pre-anthracycline treatment echocardiographic evidence of: * More than mild pericardial effusion * More than mild mitral regurgitation * Poor echocardiographic acoustic window

Primary outcome measure(s)

  • Sensitivity of change in myocardial work values 1 month after first Anthracycline chemotherapy treatment in predicting a decrease of the ejection fraction at 12 months — 12 months after first Anthracycline chemotherapy treatment
    Patients will be evaluated with a complete echocardiogram, registering ejection fraction (EF) and myocardial work (MW) before the start of Anthracycline chemotherapy (AC) treatment and 1 and 12 months after first AC treatment. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change in predicting a decrease in ejection fraction (EF). Youden index will be calculated to find the optimum value of the myocardial work (MW) discriminating the decrease or not of ejection fraction (EF).
  • Sensitivity of change in myocardial work values 6 months after first Anthracycline chemotherapy treatment in predicting a decrease of the ejection fraction at 12 months — 12 months after first Anthracycline chemotherapy treatment
    Patients will be evaluated with a complete echocardiogram, registering ejection fraction (EF) and myocardial work (MW) before the start of Anthracycline chemotherapy (AC) treatment and 6 and 12 months after first Anthracycline chemotherapy (AC) treatment. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change in predicting a decrease in ejection fraction (EF). Youden index will be calculated to find the optimum value of the myocardial work (MW) discriminating the decrease or not of ejection fraction (EF).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Burlo Garofolo Trieste Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06898320 on ClinicalTrials.gov ↗ ← All trials in Italy