Clinical trial NCT05781672: Prediction of Delayed Toxic Cardiomyopathy in Children
Official title: Longitudinal Analysis of Myocardial Function by Speckle Tracking Echocardiography and Prediction of Delayed Toxic Cardiomyopathy Associated With Anthracycline Therapy in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiotoxicity
Childhood Cancer
Keywords: Echocardiography
Ventricular function
Stroke Volume
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 134
Sex: ALL
Minimum age (years): 11
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: ANTHRA GROUP

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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Left Ventricle Ejection fraction (LVEF) by Simpson method (%)
timeFrame: The day of inclusion
measure: Left ventricular myocardial dysfunction defined by LVEF < 55%
timeFrame: 5 years
measure: Death secondary to toxic cardiomyopathy
timeFrame: 5 years
Other outcomes:
measure: Known risk factors for cardiotoxicity
timeFrame: the day of inclusion
measure: Troponin T on the experimental group
timeFrame: The day of inclusion
measure: NT-pro-BNP on the experimental group
timeFrame: The day of inclusion
measure: Known risk factors for cardiotoxicity
timeFrame: the day of inclusion
measure: Known risk factors for cardiotoxicity
timeFrame: the day of inclusion
measure: Known risk factors for cardiotoxicity
timeFrame: The day of inclusion
Locations:
city: Montpellier
country: France
facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: VINCENTI Marie, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12.