Cardiomyopathy in DMD: Lisinopril vs. Losartan

Not Applicable

Completed

• Conditions: Duchenne Muscular Dystrophy (DMD); Cardiomyopathy
• Interventions: Drug: Losartan; Drug: Lisinopril

• Registration Number: NCT01982695
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2012-08
• Study Completion: 2013-09
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Results First Submitted: 2015-08-14
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Results First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan	Losartan	-
Lisinopril	Lisinopril	-

Primary Outcome Measures

Name	Time	Method
Cardiac Ejection Fraction as Measured by Echocardiogram	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.

Trial Locations

Locations (6)

University of California Davis; 🇺🇸 Davis, California, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

St. Louis Children's Hospital; 🇺🇸 St. Louise, Missouri, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of Minnesota; 🇺🇸 St. Paul, Minnesota, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States