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Assessment of Cardiopulmonary Function in Duchenne Muscular Dystrophy

NCT02195999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2019-07-08

No results posted yet for this study

Summary

This study seeks to develop and validate non-invasive assessments of cardiac and respiratory muscles with magnetic resonance imaging (MRI) to better predict the natural disease progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle, and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.

Conditions

  • Muscular Dystrophy, Duchenne

Interventions

OTHER

Magnetic Resonance Imaging (MRI)

It is a non-invasive method to determine ventricular size, volumes, mass, and ejection fraction.

OTHER

Pulmonary Function Testing (PFT)

It is non-invasive breathing tests that characterize respiratory muscle function, as well as lung compliance and physiology.

OTHER

Metabolic Exercise Testing using stationary bicycle

Metabolic exercise testing, including assessment of exercise capacity and MVO2, evaluates global cardiopulmonary functional status. This is performed with the use of a stationary bicycle.

OTHER

Echocardiogram

The echocardiogram performed with the multiple-echo Dixon method helps to assess participants cross-sectionally and longitudinally for variations and changes in myocardial structure.

Sponsors & Collaborators

  • CureDuchenne

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Barry Byrne, MD, PhD · University of Florida

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-03-06
Completion
2019-03-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195999 on ClinicalTrials.gov