Heart InjuriesNCT06898320
Cardiac Injury Due to Anthracycline in Paediatric Oncological Patients
An observational study of Heart Injuries and Anthracycline, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Heart Injuries, Anthracycline
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2023to 21 Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric oncological patients between 0 and 18 years with planned anthracycline therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, Italy, 34137
Thomas Caiffa, MD, +390403785248, thomas.caiffa@burlo.trieste.it
About this study
Official title: Prediction of Cardiac Injury Due to Anthracycline Chemotherapy in Paediatric Oncological Patients Using Advanced Echocardiography and Circulating Biomarkers.
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.
Read the 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
- Keywords
- Cardiac injury, Anthracycline chemotherapy, echocardiography, Circulating biomarkers
- Medical subject headings
- Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anthracycline therapy | Paediatric oncological patients receiving anthracycline chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after first Anthracycline chemotherapy treatment
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).
Measured: 12 months after first Anthracycline chemotherapy treatment
Secondary outcomes (2)
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).
Measured: 12 months after first Anthracycline chemotherapy treatment
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).
Measured: 12 months after first Anthracycline chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start21 Jul 2023
- Primary completion21 Jul 2033 (estimated)
- Study completion21 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Caiffa, MD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898320
- Sponsor's protocol ID
- RC 44/2023
- Status last verified
- May 2025
- First submitted
- 20 Mar 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Cardiac Injury Due to Anthracycline Chemotherapy in Paediatric Oncological Patients Using Advanced Echocardiography and Circulating Biomarkers.
- ClinicalTrials.gov ID
- NCT06898320
- Acronym / sponsor ID
- RC 44/2023
- Conditions
- Heart Injuries, Anthracycline
- Keywords
- Cardiac injury, Anthracycline chemotherapy, echocardiography, Circulating biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Jul 2033 (estimated)
- Study completion
- 21 Jul 2033 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anthracycline therapy | – | –Paediatric oncological patients receiving anthracycline chemotherapy |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric oncological patients between 0 and 18 years with planned anthracycline therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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
Time frame: 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).
2 secondary outcomes
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
Time frame: 12 months after first Anthracycline chemotherapy treatment
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
Time frame: 12 months after first Anthracycline chemotherapy treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Caiffa, MD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Injuries and Anthracycline, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Caiffa, MD (+39 0403785248, thomas.caiffa@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months after first Anthracycline chemotherapy treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.