Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving
cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with
Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be
enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will
use a drug diary to record daily compliance of taking the study medication as well as any
concerns they may have during the study period. Subjects will undergo cardiac magnetic
resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12
months post enrollment. Subjects will also complete a quality of life questionnaire at
baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at
baseline and 12 months.
Phase:
Phase 3
Details
Lead Sponsor:
Ohio State University
Collaborators:
University of California, Los Angeles University of Colorado, Denver University of Kansas Medical Center University of Utah Vanderbilt University Vanderbilt University Medical Center