Cardiomyopathy in DMD: Lisinopril vs. Losartan

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01982695
• Date of registration: 29/10/2013
• Prospective Registration: No
• Primary sponsor: Nationwide Children's Hospital
• Public title: Cardiomyopathy in DMD: Lisinopril vs. Losartan
• Scientific 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
• Date of first enrolment: March 2009
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01982695
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Cardiomyopathy

Duchenne Muscular Dystrophy (DMD)

Intervention(s)

Drug: Losartan

Drug: Lisinopril

Primary Outcome(s)

Cardiac Ejection Fraction as Measured by Echocardiogram [Time Frame: 12 month visit]

Secondary ID(s)

IRB12-00149

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Davis

Unverisity of Kansas Medical Center

St. Louis Children's Hospital

Boston Children’s Hospital

University of Minnesota - Clinical and Translational Science Institute

Results

• Results available: Yes
• Date Posted: 21/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01982695