NCT Number: NCT01982695
Cardiomyopathy in DMD: Lisinopril vs. Losartan
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.
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Notify MeKey information
Conditions
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
University of California Davis, Davis, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Lisinopril
DrugPrimary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Nationwide Children's Hospital
Other
Collaborators
- Boston Children's Hospital
- St. Louis Children's Hospital
- University of California, Davis
- University of Kansas Medical Center
- University of Minnesota
Registry information
Official study title
Compare Efficacy of the Angiotensin Converting Enzyme Inhibitor (ACEi) Lisinopril With Angiotensin II Receptor Antagonist Losartan (ARB) for the Cardiomyopathy of Duchenne Muscular Dystrophy
Important dates
- Study start
- 2009
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Nov 13, 2013
- Registry last updated
- Mar 21, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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