Open Actively Recruiting

Validating Cardiac MRI Biomarkers and Genotype-Phenotype Correlations for DMD

About

Brief Summary

This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better understand the health of the heart and changes in heart health over time in boys with DMD.

Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical drug trials for boys with DMD. Consequently, the first objective is to identify and characterize several cardiac MRI biomarkers for boys with DMD.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
Yes
Minimum Age
7 Years
Maximum Age
21 Years

Inclusion Criteria:

  • Healthy boys or pediatric patients with DMD age 7 to 21
  • Able & willing to complete an approximately 75-minute (or less) MRI exam without sedation or mechanical ventilation
  • Drug regimen (if applicable) stable for at least 3 months prior to participation

Exclusion Criteria:

  • Renal insufficiency (GFR<40 mL/min/m2)
  • Non-MRI compatible implants (e.g. neurostimulator, pacemaker, implanted cardioverter defibrillator)
  • Claustrophobia that prevents an MRI exam
  • Known allergy to MRI contrast agents
  • Serum potassium level of >5.0 mmol/L
  • Signs and symptoms of heart failure

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
16-000297
Category
Radiological Sciences
Principal Investigator
Holden Wu
Contact
Stephanie Gilbert
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02834650
For detailed technical eligibility, visit ClinicalTrials.gov.