Cardiomyopathy in DMD: Lisinopril vs. Losartan

Plain-language summary

This study compared the drugs Lisinopril and Losartan for the heart muscle disease (cardiomyopathy) that develops in patients with Duchenne muscular dystrophy (DMD). It included DMD patients with a null mutation in the dystrophin gene or less than 5% dystrophin in muscle and an ejection fraction below 55%. The study was carried out as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Nationwide Children's Hospital

Intervention

Losartan, Lisinopril

Start date

3/1/2009

Estimated completion

9/1/2013

Countries

United States

Related genes

Locations

• Davis, United States
• Kansas City, United States
• Boston, United States
• Saint Paul, United States
• Saint Louise, United States
• Columbus, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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