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Prediction of Delayed Toxic Cardiomyopathy in Children

Longitudinal Analysis of Myocardial Function by Speckle Tracking Echocardiography and Prediction of Delayed Toxic Cardiomyopathy Associated With Anthracycline Therapy in Children

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05781672
Acronym
SpeckleAnthra2
Enrollment
134
Registered
2023-03-23
Start date
2023-03-16
Completion date
2025-01-07
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Childhood Cancer

Keywords

Echocardiography, Ventricular function, Stroke Volume

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.

Interventions

DIAGNOSTIC_TESTcardiac ultrasound with speckle tracking analysis

Experimental group: cardiac ultrasound with speckle tracking analysis done during a regular cardiac visit planned after receiving cardiotoxic chemotherapy in childhood. Control group: cardiac ultrasound with speckle tracking analysis done during a cardiac visit for minor symptoms (murmur, physical aptitude). Advocated Tomtec software will be used to make post-processing speckle tracking analysis based on 2D ultrasound cineloop acquired during a standard echocardiography.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 27 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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 yearsTo 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

MeasureTime frameDescription
Left Ventricle Ejection fraction (LVEF) by Simpson method (%)The day of inclusionCompare 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 yearsCorrelation 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 cardiomyopathy5 yearsCorrelation 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

Other

MeasureTime frameDescription
Troponin T on the experimental groupThe day of inclusionTroponin T is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in ng/ml. normal troponin value is between 0 and 0.04 ng/mL
NT-pro-BNP on the experimental groupThe day of inclusionNT-pro-BNP (N terminal-pro-brain natriuretic peptides) is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in pg/ml. Normal NT-proBNP value is \< 400pg/ml
Known risk factors for cardiotoxicitythe day of inclusionTo assess the effect of known risk factors for anthracycline cardiotoxicity, the anthracycline cumulative dose will be collected

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026