NCT02418338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

3.4 years

First QC Date

April 13, 2015

Last Update Submit

June 5, 2019

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • global longitudinal LV 2D strain

    day 1

Study Arms (2)

dmd children

EXPERIMENTAL

echocardiography

Other: speckle tracking (2D strain) echocardiography

healthy children

OTHER

echocardiography

Other: speckle tracking (2D strain) echocardiography

Interventions

speckle tracking (2D strain) echocardiographyOTHER

2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation

dmd childrenhealthy children

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (2)

  • 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.

    PMID: 30679141BACKGROUND

  • 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.

    PMID: 34905152DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pascal AMEDRO, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Pierre MP Meyer, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Arnaud BERTRAND, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Jean-Michel RAUZIER, MD, PhD

    UH Nîmes

    PRINCIPAL INVESTIGATOR

  • Charlène BREDY, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • François RIVIER, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Grégoire DE LA VILLEON, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Ulrike WALTHER-LOUVIER, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Sophie GUILLAUMONT, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Camille SOULATGES, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Marie VINCENTI, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

FR(1)