Prediction of Delayed Toxic Cardiomyopathy in Children

NCT ID: NCT05781672

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2025-01-07

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.

Conditions

Cardiotoxicity; Childhood Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anthra2

Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787)

Group Type: EXPERIMENTAL

cardiac ultrasound with speckle tracking analysis

Intervention Type: DIAGNOSTIC_TEST

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.

Control

Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group

Group Type: ACTIVE_COMPARATOR

cardiac ultrasound with speckle tracking analysis

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

cardiac 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

• 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

• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VINCENTI Marie, PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 35167907 (View on PubMed)

Other Identifiers

RECHMPL22_0513

Identifier Type: -

Identifier Source: org_study_id