Status:
COMPLETED
Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy
Lead Sponsor:
Subha Raman
Collaborating Sponsors:
Ballou Skies
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
7+ years
Phase:
NA
Brief Summary
Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and cardiac muscle damage. Treatment of pulmonary complications has improved survival; however, heart muscle di...
Detailed Description
Duchenne Muscular dystrophy (DMD) is a deadly X-linked disease affecting 1 in 3,500 males. DMD patients suffer significant disability due to skeletal myopathy and excess death due to cardiomyopathy. C...
Eligibility Criteria
Inclusion
- DMD patients age 7 years and older (and able to complete cardiac MRI without sedation) with preserved left ventricular (LV) systolic function and abnormal heart muscle by late post-gadolinium imaging (LGE)
Exclusion
- renal insufficiency (GFR \<40 mL/min/m2)
- non-MR compatible implants (e.g. neurostimulator, AICD)
- severe claustrophobia
- allergy to gadolinium contrast
- prior use of or known allergy to epleronone
- use of potassium-sparing diuretics
- serum potassium level of \>5.0 mmol/L
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01521546
Start Date
February 1 2012
End Date
June 1 2016
Last Update
November 8 2016
Active Locations (3)
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1
Mattel Children's Hospital and David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1743
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
3
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210