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临床试验/NCT01982695
NCT01982695已完成不适用

Compare Efficacy of the Angiotensin Converting Enzyme Inhibitor (ACEi) Lisinopril With Angiotensin II Receptor Antagonist Losartan (ARB) for the Cardiomyopathy of Duchenne Muscular Dystrophy

Nationwide Children's Hospital6 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
6
主要终点
Cardiac Ejection Fraction as Measured by Echocardiogram

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Lisinopril

Active Comparator

干预措施: Lisinopril (Drug)

Losartan

Active Comparator

干预措施: Losartan (Drug)

结局指标

主要结局

Cardiac Ejection Fraction as Measured by Echocardiogram

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerry R. Mendell

Director, Center for Gene Therapy

Nationwide Children's Hospital

研究点 (6)

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Cardiomyopathy in DMD: Lisinopril vs. Losartan | 临床试验