Duchenne Muscular DystrophyDMD-CMPNCT05558813
Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)
A study testing Cardiac MRI and Blood assays in people with Duchenne Muscular Dystrophy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays. Read more about this study
- Who is it for?
- Ages 6 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Cardiac MRI and Blood assays
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2024to Apr 2029
- 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 6 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >= 6 years
- Genetically proven Duchenne muscular dystrophy
- Affiliation to French medical insurance
- Informed consent provided
Who cannot join
- Age <6 years
- Left ventricular ejection fraction <30%
- Tracheostomy of hospitalisation for acute respiratory failure <1 year
- Contraindication to MRI: claustrophobia, Gadolinum allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)
The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.
Read the detailed description
This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Cardiac MRI, Blood assays
- Keywords
- Duchenne, dystrophin, cardiomyopathy, cardiac MRI
- Medical subject headings
- Muscular Dystrophy, Duchenne, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
two cardiac MRIs with Gadolinum injection at 2-year intervals
Blood assaysBiological
Also called Blood biobanking
blood samples for the determination of blood biomarkers of heart failure (BNP, NTproBNP) and for the constitution of a biological collection
| Study group | Role | What they receive |
|---|---|---|
| DMD-CMP cohort | Experimental | Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy Receives: Diagnostic Test: Cardiac MRI; Biological: Blood assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late gadolinium enhancement burden on cardiac MRI
Measured: 2 years
Secondary outcomes (9)
Global T1 on cardiac MRI
Measured: 2 years
Global T2 on cardiac MRI
Measured: 2 years
Global extracellular volume on cardiac MRI
Measured: 2 years
Left ventricular ejection fraction on cardiac MRI
Measured: 2 years
Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI
Measured: 2 years
Left ventricular systolic radial strain ejection fraction on cardiac MRI
Measured: 2 years
Left ventricular systolic longitudinal strain on cardiac MRI
Measured: 2 years
NTproBNP assay in the blood
Measured: 2 years
Troponin I assay in the blood
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study startNov 2024 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionApr 2029 (estimated)
Why it stopped: Cancellation of financing by the financier.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Karim A WAHBI, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558813
- Sponsor's protocol ID
- APHP220088
- Other IDs
- 2020-A03534-35
- Acronym
- DMD-CMP
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)
- ClinicalTrials.gov ID
- NCT05558813
- Acronym / sponsor ID
- DMD-CMP / APHP220088
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne, dystrophin, cardiomyopathy, cardiac MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancellation of financing by the financier.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2024 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 28 Sep 2022 (actual)
- 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.
The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.
Detailed description
This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMD-CMP cohort | Experimental | Diagnostic Test: Cardiac MRI, Biological: Blood assaysMinor (≥ 6 years) and major patients with genetically proven Duchenne myopathy |
Who may qualify
- Ages
- 6 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 6 years
- Genetically proven Duchenne muscular dystrophy
- Affiliation to French medical insurance
- Informed consent provided
Key exclusion criteria (4 listed)
- Age <6 years
- Left ventricular ejection fraction <30%
- Tracheostomy of hospitalisation for acute respiratory failure <1 year
- Contraindication to MRI: claustrophobia, Gadolinum allergy
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 |
|---|---|---|
| Cardiac MRItwo cardiac MRIs with Gadolinum injection at 2-year intervals | Diagnostic test | DMD-CMP cohort |
| Blood assaysAlso: Blood biobankingblood samples for the determination of blood biomarkers of heart failure (BNP, NTproBNP) and for the constitution of a biological collection | Biological | DMD-CMP cohort |
Primary outcome
Late gadolinium enhancement burden on cardiac MRI
Time frame: 2 years
9 secondary outcomes
Global T1 on cardiac MRI
Time frame: 2 years
Global T2 on cardiac MRI
Time frame: 2 years
Global extracellular volume on cardiac MRI
Time frame: 2 years
Left ventricular ejection fraction on cardiac MRI
Time frame: 2 years
Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI
Time frame: 2 years
Left ventricular systolic radial strain ejection fraction on cardiac MRI
Time frame: 2 years
Left ventricular systolic longitudinal strain on cardiac MRI
Time frame: 2 years
NTproBNP assay in the blood
Time frame: 2 years
Troponin I assay in the blood
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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.
Karim A WAHBI, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI and Blood assays in people with Duchenne Muscular Dystrophy, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Nov 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Late gadolinium enhancement burden on cardiac MRI (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.