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ClinicalTrials.gov Identifier: NCT01982695
Recruitment Status :
First Posted : November 13, 2013
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Nationwide Children's Hospital
Boston Children’s Hospital
University of California, Davis
Unverisity of Kansas Medical Center
University of Minnesota - Clinical and Translational Science Institute
This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.
Cardiac Ejection Fraction as Measured by Echocardiogram [ Time Frame: 12 month visit ]
Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson's rule using images obtained from the apical 4 chamber views of the heart.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Duchenne muscular dystrophy patients of all ages
Null mutation of the dystrophin gene or muscle with <5% dystrophin
Doppler echocardiogram with ejection fraction (EF) <55% within 30 days of enrollment
Ability to cooperate for testing
Glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort
Patients with EF 55% or greater
Patients with EF <40% after washout
Patients taking >5 mg lisinopril, or >25 mg losartan or >5 mg enalapril
Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography