Cardiac Injury Due to Anthracycline in Paediatric Oncological Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorIRCCS Burlo Garofolo
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous anthracycline treatment, bone marrow transplantation or chest radiation
More than mild pericardial effusion
More than mild mitral regurgitation
Poor echocardiographic acoustic window
Trial population
Paediatric oncological patients between 0 and 18 years with planned anthracycline therapy
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
22 Participants
are grouped into 1 trial groupGroup A: Anthracycline therapy
Trial outcomes
Primary outcomes
1
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
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).
Time frame
12 months after first Anthracycline chemotherapy treatment2
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
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).
Time frame
12 months after first Anthracycline chemotherapy treatmentSecondary outcomes
1
Sensitivity of change in myocardial work values 1 month after first Anthracycline chemotherapy treatment combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease of the ejection fraction at 12 months
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 Anthracycline chemotherapy (AC) treatment. Troponin-I hs and N-terminal pro b-type natriuretic peptide (NT-proBNP) will be evaluated in blood. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease in ejection fraction (EF).
Time frame
12 months after first Anthracycline chemotherapy treatment2
Sensitivity of change in myocardial work values 6 months after first Anthracycline chemotherapy treatment combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease of the ejection fraction at 12 months
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 Anthracycline chemotherapy (AC) treatment. Troponin-I hs and N-terminal pro b-type natriuretic peptide (NT-proBNP) will be evaluated in blood. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease in ejection fraction (EF).
Time frame
12 months after first Anthracycline chemotherapy treatmentSponsors and contacts
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Source ClinicalTrials.gov