Prediction of Delayed Toxic Cardiomyopathy in Children

NCT05781672 | Terminated

• 1 other identifier: RECHMPL22_0513
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Childhood Cancer

Keywords

Echocardiography; Ventricular function; Stroke Volume

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  5 years

Secondary Outcomes (3)

• Left Ventricle Ejection fraction (LVEF) by Simpson method (%)

  The day of inclusion

• Left ventricular myocardial dysfunction defined by LVEF < 55%

  5 years

• Death secondary to toxic cardiomyopathy

  5 years

Other Outcomes (6)

• Known risk factors for cardiotoxicity

  the day of inclusion

• Troponin T on the experimental group

  The day of inclusion

• NT-pro-BNP on the experimental group

  The day of inclusion

Study Arms (2)

Anthra2

EXPERIMENTAL

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

Diagnostic Test: cardiac ultrasound with speckle tracking analysis

Control

ACTIVE COMPARATOR

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

Diagnostic Test: cardiac ultrasound with speckle tracking analysis

Interventions

cardiac ultrasound with speckle tracking analysis 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.

Anthra2; Control

Eligibility Criteria

• Age: 11 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 35167907 BACKGROUND

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• VINCENTI Marie, PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 23, 2023
• Study Start: March 16, 2023
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 5years
• Access Criteria: Clinical trials

Locations

FR (1)