Clinical trial NCT02418338: 2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children
Official title: Evaluation of Myocardial Function by Two Dimensional Speckle Tracking Echocardiography in Children With Duchenne Muscular Dystrophy Versus Healthy Children: a Comparative Transversal Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 99
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

Detailed description: Among the new echocardiographic techniques, two dimensional Speckle Tracking Imaging or "2D Strain" allows a dynamic study of regionalized and global ventricular contraction. With software for the spatial and temporal processing of a standard 2D image, this technique measures the displacement of natural markers present on the myocardial wall.

Used in adult cardiology since 2000, it could be eligible to pediatric population because of many potential applications. In Duchenne muscular dystrophy, myocardial disease leads to death in the third decade. Early diagnosis and preventive therapy remain a challenge. No clinic, biologic or radiologic markers can predict myocardial disease before advanced and irreversible heart failure.

Recent animals and human studies suggest that 2D strain anomalies could predict left ventricular systolic dysfunction in Duchenne muscular dystrophy. If it is confirmed, 2D strain could be used as early marker of myocardial disease in routine patient follow-up and in future therapeutic studies.

Purpose : - To compare systolic function of left ventricle (LV) and right ventricle (RV) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

* To correlate 2D Strain variables to conventional LV and RV echo variables.
* To evaluate 2D strain feasibility in normal children and Duchenne muscular myopathy population

Eligibility criteria: Inclusion Criteria:

* Duchenne's muscular dystrophy (group 1) followed in our institution's referral center of neuromuscular diseases, during regular annual echocardiography follow-up.
* Healthy children (group 2), addressed in pediatric cardiology

Primary outcomes:
measure: global longitudinal LV 2D strain
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study officials:
affiliation: UH Montpellier
name: Pascal AMEDRO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Pierre MP Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Arnaud BERTRAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Nîmes
name: Jean-Michel RAUZIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Charlène BREDY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: François RIVIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Grégoire DE LA VILLEON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Ulrike WALTHER-LOUVIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Sophie GUILLAUMONT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Camille SOULATGES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Montpellier
name: Marie VINCENTI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amedro P, Vincenti M, De La Villeon G, Lavastre K, Barrea C, Guillaumont S, Bredy C, Gamon L, Meli AC, Cazorla O, Fauconnier J, Meyer P, Rivier F, Adda J, Mura T, Lacampagne A. Speckle-Tracking Echocardiography in Children With Duchenne Muscular Dystrophy: A Prospective Multicenter Controlled Cross-Sectional Study. J Am Soc Echocardiogr. 2019 Mar;32(3):412-422. doi: 10.1016/j.echo.2018.10.017. Epub 2019 Jan 21.
citation: Lanot N, Vincenti M, Abassi H, Bredy C, Agullo A, Gamon L, Mura T, Lavastre K, De La Villeon G, Barrea C, Meyer P, Rivier F, Meli AC, Fauconnier J, Cazorla O, Lacampagne A, Amedro P. Assessment of left ventricular dyssynchrony by speckle tracking echocardiography in children with duchenne muscular dystrophy. Int J Cardiovasc Imaging. 2022 Jan;38(1):79-89. doi: 10.1007/s10554-021-02369-y. Epub 2021 Dec 14.