Cardiac Injury Due to Anthracycline in Paediatric Oncological Patients

NCT ID: NCT06898320

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2033-07-21

Brief 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.

Detailed Description

Anthracycline chemotherapy (AC) can cause dose-related cardiomyocyte injury and death, possibly leading to left ventricular dysfunction. The most commonly accepted pathophysiological mechanism of anthracycline-induced cardiotoxicity is the oxidative stress hypothesis, which suggests that the generation of reactive oxygen species and lipid peroxidation of the cell membrane damage cardiomyocytes. However, there is considerable variability among patients in their susceptibility to anthracyclines: while many tolerate standard-dose anthracyclines without long-term complications, treatment-related cardiotoxicity may occur as early as after the first dose in other patients.

An increase in cancer survival, along with better awareness of the possible late effects of cardiotoxicity, has led to growing recognition of the need for surveillance of anthracycline-treated cancer survivors to prevent the development of heart failure.

Strategies for screening and detection of cardiotoxicity include cardiac imaging [echocardiography, nuclear imaging, cardiac magnetic resonance (CMR)] and biomarkers (troponin, natriuretic peptides).

The echocardiographic clinical standards for measuring left ventricular (LV) systolic function are LV ejection fraction (LVEF) and global longitudinal strain (GLS) with the latter as a more sensitive parameter to detect mild systolic dysfunction. There is abundant documentation that left ventricular ejection fraction (LVEF) is useful to guide clinical decisions, and emerging data show the clinical value of measuring global longitudinal strain (GLS). In the past, a study investigated the role of conventional- and speckle-tracking echocardiography in a cohort of asymptomatic children after anthracycline therapy, showing that impaired left ventricular myocardial deformation and mechanical dyssynchrony may exist after anthracycline therapy despite having normal left ventricular shortening fractions.

However, both left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) depend on left ventricular (LV) afterload and do not provide information regarding the ventricle's efficiency. Recently, the use of non-invasive myocardial work (MW) was proposed to measure left ventricular systolic function in a way that incorporates afterload and has the potential to quantify left ventricular (LV) energy waste.

Noninvasive myocardial work (MW) is a robust and reproducible index of left ventricular (LV) systolic performance. It correlates with myocardial metabolism and shows less afterload dependency than left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS).

Different studies have shown the potential role of myocardial work (MW) in predicting the response to cardiac resynchronisation therapy (CRT) in patients with heart failure and reduced ejection fraction (HFrEF). However, the role of myocardial work (MW) in cancer paediatric patients has not yet been fully investigated.

Conditions

Heart Injuries; Anthracycline

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Anthracycline therapy

Paediatric oncological patients receiving anthracycline chemotherapy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Caiffa, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo

Locations

IRCCS Burlo Garofolo

Trieste, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Thomas Caiffa, MD

Role: CONTACT

thomas.caiffa@burlo.trieste.it

+39 0403785248

Facility Contacts

Thomas Caiffa, MD

Role: primary

thomas.caiffa@burlo.trieste.it

+390403785248

Other Identifiers

RC 44/2023

Identifier Type: -

Identifier Source: org_study_id