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N/A N=23 Randomized Quadruple-blind Treatment

Cardiomyopathy in DMD: Lisinopril vs. Losartan

Duchenne Muscular Dystrophy (DMD) · Cardiomyopathy

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Cardiac Ejection Fraction as Measured by Echocardiogram — 54.6; 55.2 percentage of blood leaving the heart

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Losartan (Drug); Lisinopril (Drug)
Age
Pediatric, Adult, Older Adult
Sex
Male
Sponsor
Nationwide Children's Hospital
Primary completion
Aug 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Cardiac Ejection Fraction as Measured by Echocardiogram
54.6; 55.2

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.

Eligibility Criteria

Inclusion Criteria

  • Duchenne muscular dystrophy patients of all ages
  • Null mutation of the dystrophin gene or muscle with 5 mg lisinopril, or >25 mg losartan or >5 mg enalapril
  • Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01982695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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