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Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)

Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05558813
Acronym
DMD-CMP
Enrollment
0
Registered
2022-09-28
Start date
2024-11-30
Completion date
2029-04-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne, dystrophin, cardiomyopathy, cardiac MRI

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTCardiac MRI

two cardiac MRIs with Gadolinum injection at 2-year intervals

BIOLOGICALBlood assays

blood samples for the determination of blood biomarkers of heart failure (BNP, NTproBNP) and for the constitution of a biological collection

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

: * Age \>= 6 years * Genetically proven Duchenne muscular dystrophy * Affiliation to French medical insurance * Informed consent provided

Exclusion criteria

: * Age \<6 years * Left ventricular ejection fraction \<30% * Tracheostomy of hospitalisation for acute respiratory failure \<1 year * Contraindication to MRI: claustrophobia, Gadolinum allergy

Design outcomes

Primary

MeasureTime frame
Late gadolinium enhancement burden on cardiac MRI2 years

Secondary

MeasureTime frame
Global T2 on cardiac MRI2 years
Global extracellular volume on cardiac MRI2 years
Left ventricular ejection fraction on cardiac MRI2 years
Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI2 years
Global T1 on cardiac MRI2 years
Left ventricular systolic longitudinal strain on cardiac MRI2 years
NTproBNP assay in the blood2 years
Troponin I assay in the blood2 years
Left ventricular systolic radial strain ejection fraction on cardiac MRI2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026