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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01982695
Other study ID # IRB12-00149
Secondary ID
Status Completed
Phase N/A
First received October 29, 2013
Last updated November 5, 2013
Start date March 2009
Est. completion date September 2013

Study information

Verified date November 2013
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date September 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Losartan

Lisinopril


Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts
United States Nationwide Children's Hospital Columbus Ohio
United States University of California Davis Davis California
United States University of Kansas Medical Center Kansas City Kansas
United States St. Louis Children's Hospital St. Louise Missouri
United States University of Minnesota St. Paul Minnesota

Sponsors (6)

Lead Sponsor Collaborator
Nationwide Children's Hospital Children's Hospital Boston, St. Louis Children's Hospital, University of California, Davis, University of Minnesota - Clinical and Translational Science Institute, Unverisity of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Thrush PT, Allen HD, Viollet L, Mendell JR. Re-examination of the electrocardiogram in boys with Duchenne muscular dystrophy and correlation with its dilated cardiomyopathy. Am J Cardiol. 2009 Jan 15;103(2):262-5. doi: 10.1016/j.amjcard.2008.08.064. Epub 2008 Oct 30. — View Citation

Viollet L, Thrush PT, Flanigan KM, Mendell JR, Allen HD. Effects of angiotensin-converting enzyme inhibitors and/or beta blockers on the cardiomyopathy in Duchenne muscular dystrophy. Am J Cardiol. 2012 Jul 1;110(1):98-102. doi: 10.1016/j.amjcard.2012.02. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Pulmonary function testing Forced vital capacity (FVC) will be measured using a spirometer. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits. Every 12 months for 2 years No
Other Changes in activities of daily living Measured using the Egen Klassification (EK) Scale. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits. Every 12 months for 2 years No
Other Health related quality of life Measured using the PedsQL. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits. Every 12 months for 2 years No
Primary Cardiac ejection fraction as measured by echocardiogram Participants will have a baseline visit and then followed every four months for the duration study, anticipated for a total of 2 years. Every 4 months for 2 years Yes
Secondary Skeletal muscle strength Muscle strength will be measured by hand held dynamometer. Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits. Every 12 months for 2 years No
Secondary Skeletal Muscle function Skeletal muscle function will be measured by Brooke Upper Extremity Functional Rating Scale, Nine-Hole-Peg test, and 6-minute walk test (6MWT). Participants will have a measurement collected at their baseline visit and then again at their 1 and 2 year visits. Every 12 months for 2 years No
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