Duchenne Muscular DystrophyNCT02418338
2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children
A study testing speckle tracking (2D strain) echocardiography in people with Duchenne Muscular Dystrophy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- speckle tracking (2D strain) echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
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
Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.
Read the 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
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- speckle tracking (2D strain) echocardiography
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking (2D strain) echocardiographyOther
2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation
| Study group | Role | What they receive |
|---|---|---|
| dmd children | Experimental | echocardiography Receives: Other: speckle tracking (2D strain) echocardiography |
| healthy children | Other | echocardiography Receives: Other: speckle tracking (2D strain) echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
global longitudinal LV 2D strain
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, UH MontpellierPierre MP Meyer, MD, PhD, Principal investigator, UH MontpellierArnaud BERTRAND, MD, PhD, Principal investigator, UH MontpellierJean-Michel RAUZIER, MD, PhD, Principal investigator, UH NîmesCharlène BREDY, MD, PhD, Principal investigator, UH MontpellierFrançois RIVIER, MD, PhD, Principal investigator, UH MontpellierGrégoire DE LA VILLEON, MD, PhD, Principal investigator, UH MontpellierUlrike WALTHER-LOUVIER, MD, PhD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418338
- Sponsor's protocol ID
- 9458
- Status last verified
- Jun 2019
- First submitted
- 13 Apr 2015
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30679141Lanot 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.
PubMed 34905152
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02418338
- Acronym / sponsor ID
- 9458
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dmd children | Experimental | Other: speckle tracking (2D strain) echocardiographyechocardiography |
| healthy children | Other | Other: speckle tracking (2D strain) echocardiographyechocardiography |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speckle tracking (2D strain) echocardiography2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation | Other | dmd children, healthy children |
Primary outcome
global longitudinal LV 2D strain
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 30679141Amedro 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.
- Derived from this study: PubMed 34905152Lanot 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.
Related trials for Duchenne Muscular Dystrophy
RecruitingEarly Phase 1
Safety and Dystrophin Expression of SPOT-03 in Duchenne Muscular Dystrophy (DMD) Patients
Duchenne Muscular Dystrophy (DMD)
RecruitingPhase 2
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Not yet recruitingPhase 2
A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD)
Not yet recruitingObservational study
Multimodal Study About Absence of Dp140 in Becker Muscular Dystrophy: Brain-muscle Imaging, Cognition and Muscle Function
Becker Muscular Dystrophy
Enrolling by invitationObservational study
A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practice
Duchenne Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD, PhD principal investigator
UH Montpellier
Pierre MP Meyer, MD, PhD principal investigator
UH Montpellier
Arnaud BERTRAND, MD, PhD principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speckle tracking (2D strain) echocardiography in people with Duchenne Muscular Dystrophy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global longitudinal LV 2D strain (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418338, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.