NCT07674758 Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials
| NCT ID | NCT07674758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-01-06 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dystrophin associated heart dysfunction is a leading cause of death in patients with Duchenne and Becker Muscular dystrophy (DMD/BMD) and Duchenne and Becker muscular dystrophy carriers (MDC); however, the evolution of heart dysfunction is not well-understood. The central objectives of this proposal are to elucidate this evolution of heart dysfunction and identify measures from cardiac MRI images that can predict death or significant heart disease in patients with DMD/BMD/MDC. This study will create a large clinical and cardiac MRI registry of dystrophin associated heart dysfunction, will utilize advanced image analysis techniques, including deep learning neural networks, to comprehensively evaluate every patient, and will create a risk toolkit accessible to clinicians around the world; this proposal has the potential to improve the quality of life in patients with dystrophin associated heart dysfunction by allowing for earlier and more intensive therapy in patients with severe disease and by identifying surrogate outcome measures for use in therapeutic trials.
Eligibility Criteria
Inclusion Criteria: * Clinical phenotype of Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), or muscular dystrophy carrier (MDC) confirmed with muscle biopsy or genotype Exclusion Criteria: * Additional genetic or congenital abnormality that may affect cardiovascular function or progression * Current investigational therapy that may affect cardiovascular function (would preclude ongoing data collection but prior data would still be used)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07674758 clinical trial?
This trial is open to participants of all sexes, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07674758 currently recruiting?
Yes, NCT07674758 is actively recruiting participants. Contact the research team at DMDMachineLearning@vumc.org for enrollment information.
Where is the NCT07674758 trial being conducted?
This trial is being conducted at Sacramento, United States, Washington D.C., United States, Chicago, United States, Indianapolis, United States and 5 additional locations.
Who is sponsoring the NCT07674758 clinical trial?
NCT07674758 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 1,000 participants.