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

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMD-CMP cohort
Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy
Diagnostic test: Cardiac MRI
two cardiac MRIs with Gadolinum injection at 2-year intervals
Biological: Blood assays
blood samples for the determination of blood biomarkers of heart failure (BNP, NTproBNP) and for the constitution of a biological collection
Other Names:
  • Blood biobanking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late gadolinium enhancement burden on cardiac MRI
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Global T1 on cardiac MRI
Time Frame: 2 years
2 years
Global T2 on cardiac MRI
Time Frame: 2 years
2 years
Global extracellular volume on cardiac MRI
Time Frame: 2 years
2 years
Left ventricular ejection fraction on cardiac MRI
Time Frame: 2 years
2 years
Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI
Time Frame: 2 years
2 years
Left ventricular systolic radial strain ejection fraction on cardiac MRI
Time Frame: 2 years
2 years
Left ventricular systolic longitudinal strain on cardiac MRI
Time Frame: 2 years
2 years
NTproBNP assay in the blood
Time Frame: 2 years
2 years
Troponin I assay in the blood
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Karim A WAHBI, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220088
  • 2020-A03534-35 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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