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Prediction of Delayed Toxic Cardiomyopathy in Children (SpeckleAnthra2)

Primary Purpose

Cardiotoxicity, Childhood Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac ultrasound with speckle tracking analysis
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiotoxicity focused on measuring Echocardiography, Ventricular function, Stroke Volume

Eligibility Criteria

11 Years - 27 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anthra2

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2023
Last Updated
March 23, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05781672
Brief Title
Prediction of Delayed Toxic Cardiomyopathy in Children
Acronym
SpeckleAnthra2
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
March 16, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiotoxicity, Childhood Cancer
Keywords
Echocardiography, Ventricular function, Stroke Volume

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anthra2
Arm Type
Experimental
Arm Description
Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group
Intervention Type
Diagnostic Test
Intervention Name(s)
cardiac ultrasound with speckle tracking analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Left Ventricle Ejection fraction (LVEF) by Simpson method (%)
Description
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.
Time Frame
The day of inclusion
Title
Left ventricular myocardial dysfunction defined by LVEF < 55%
Description
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
Time Frame
5 years
Title
Death secondary to toxic cardiomyopathy
Description
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
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Known risk factors for cardiotoxicity
Description
To assess the effect of known risk factors for anthracycline cardiotoxicity, the anthracycline cumulative dose will be collected
Time Frame
the day of inclusion
Title
Troponin T on the experimental group
Description
Troponin 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
Time Frame
The day of inclusion
Title
NT-pro-BNP on the experimental group
Description
NT-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
Time Frame
The day of inclusion
Title
Known risk factors for cardiotoxicity
Description
To assess the effect of known risk factors for anthracycline cardiotoxicity, young age at administration will be collected
Time Frame
the day of inclusion
Title
Known risk factors for cardiotoxicity
Description
To assess the effect of known risk factors for anthracycline cardiotoxicity, female gender, will be collected
Time Frame
the day of inclusion
Title
Known risk factors for cardiotoxicity
Description
To assess the effect of known risk factors for anthracycline cardiotoxicity, association with mediastinal radiotherapy will be collected
Time Frame
The day of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VINCENTI Marie, PH
Phone
04 67 33 66 39
Email
m-vincenti@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
SAUMET Laure, PH
Phone
04 67 33 66 39
Email
l-saumet@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VINCENTI Marie, PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie VINCENTI, MD, PhD
Phone
0467336635
Email
m-vincenti@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
sharing of results after obtaining
IPD Sharing Time Frame
5years
IPD Sharing Access Criteria
Clinical trials
IPD Sharing URL
https://clinicaltrials.gov
Citations:
PubMed Identifier
35167907
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.
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Prediction of Delayed Toxic Cardiomyopathy in Children

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