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2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children

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ClinicalTrials.gov Identifier: NCT02418338
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Other: speckle tracking (2D strain) echocardiography Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: dmd children
echocardiography
Other: speckle tracking (2D strain) echocardiography
2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation

healthy children
echocardiography
Other: speckle tracking (2D strain) echocardiography
2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation




Primary Outcome Measures :
  1. global longitudinal LV 2D strain [ Time Frame: day 1 ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418338


Locations
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France
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: 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

Publications:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02418338     History of Changes
Other Study ID Numbers: 9458
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked