Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
Completed · Phase 3
Conditions studied: Duchenne Muscular Dystrophy
In brief
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.
Key facts
- Study ID
- NCT02354352
- Run by
- Ohio State University
- People needed
- 52
- Starts
- 2015-03-20
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2019-10-07
Who can join
Age: 7 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to undergo cardiac magnetic resonance (CMR) without sedation
- LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac MRI done within 2 weeks of enrollment
You may not qualify if…
- Non-MR compatible implants
- Severe claustrophobia
- Gadolinium contrast allergy
- Kidney disease
- Prior use of or allergy to aldosterone antagonist
- Use of other investigational therapy.
Where it is running
- Mattel Children's Hospital and David Geffen School of Medicine at UCLA — Los Angeles, California, United States
- University of Colorado — Aurora, Colorado, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- The Ohio State University Medical Center — Columbus, Ohio, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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