Prediction of Delayed Toxic Cardiomyopathy in Children

Not Applicable

Terminated

• Conditions: Childhood Cancer; Cardiotoxicity
• Interventions: Diagnostic Test: cardiac ultrasound with speckle tracking analysis

• Registration Number: NCT05781672
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.

Detailed Description

Anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts patient's life. The main recognized risk factors for delayed cardiotoxicity are cumulative anthracycline dose, female gender, association with mediastinal radiotherapy and young age at administration. Prediction of delayed cardiotoxicity in children population is still challenging.

The "Speckle Tracking Echocardiography" (STE) method, an innovative echocardiographic technique, analyses the myocardial displacement of natural acoustic markers via a software. The objective of the study is to analyze, in young patients who received anthracycline therapy in childhood, 5-years after their inclusion in the "Speckle Anthra" study and first STE results, the evolution of myocardial function using STE method.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-10
• Study Start: 2023-03-16
• Study First Posted: 2023-03-23
• Primary Completion: 2025-01-07
• Study Completion: 2025-01-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Patients who were treated with anthracyclines for malignant disease between the ages of 0 and 18
• Patient aged 11 to 27 years
• Included in the "SpeckleAnthra" Study (NCT02893787)
• Discontinued chemotherapy for more than 6 years
• Patient in remission of malignant disease
• Enrolled in a social security plan
• Written informed consent from at least one legal representative for the minor patient/ Written informed consent for patients of legal age

Exclusion Criteria

• Onset of active malignancy or recurrence of malignancy after the "Speckle Anthra" study that required resumption of chemotherapy or mediastinal radiotherapy.
• Chronic cardiac, pulmonary or muscular pathology of etiology other than secondary to anthracycline therapy
• For adult patients: subject under guardianship or curators

CONTROL GROUP

Inclusion Criteria:

• Control patient included in the "Speckle Control" study (NCT02056925)
• Had a cardiological consultation with echocardiography performed for a banal reason (heart murmur test, cardiological symptoms) and whose result was normal
• No chronic disease or long-term drug treatment

Exclusion Criteria:

• Refusal to participate in the study by the patient and/or parents or legal guardian after receipt of the study's information and non-objection note.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anthra2	cardiac ultrasound with speckle tracking analysis	Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787)
Control	cardiac ultrasound with speckle tracking analysis	Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group

Primary Outcome Measures

Name	Time	Method
Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software.	5 years	To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers.

Secondary Outcome Measures

Name	Time	Method
Left Ventricle Ejection fraction (LVEF) by Simpson method (%)	The day of inclusion	Compare the standard ultrasound parameter LVEF and the LVGLS obtained in "Speckle Anthra 2" on patients treated with anthracyclines in childhood and in the group of healthy volunteers.
Left ventricular myocardial dysfunction defined by LVEF < 55%	5 years	Correlation between the left ventricular myocardial dysfunction is defined by FeVG \< 55% and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study
Death secondary to toxic cardiomyopathy	5 years	Correlation between the rate of patients died with a toxic cardiomyopathy and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study

Trial Locations

Locations (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital; 🇫🇷 Montpellier, France