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Cardiomyopathy in DMD: Lisinopril vs. Losartan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982695
First Posted: November 13, 2013
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boston Children’s Hospital
University of California, Davis
Unverisity of Kansas Medical Center
University of Minnesota - Clinical and Translational Science Institute
St. Louis Children's Hospital
Information provided by (Responsible Party):
Jerry R. Mendell, Nationwide Children's Hospital
  Purpose
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.

Condition Intervention
Duchenne Muscular Dystrophy (DMD) Cardiomyopathy Drug: Losartan Drug: Lisinopril

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Jerry R. Mendell, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Cardiac Ejection Fraction as Measured by Echocardiogram [ Time Frame: 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.


Enrollment: 23
Study Start Date: March 2009
Study Completion Date: September 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisinopril Drug: Lisinopril
Active Comparator: Losartan Drug: Losartan

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982695


Locations
United States, California
University of California Davis
Davis, California, United States
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States
United States, Minnesota
University of Minnesota
St. Paul, Minnesota, United States
United States, Missouri
St. Louis Children's Hospital
St. Louise, Missouri, United States
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States
Sponsors and Collaborators
Nationwide Children's Hospital
Boston Children’s Hospital
University of California, Davis
Unverisity of Kansas Medical Center
University of Minnesota - Clinical and Translational Science Institute
St. Louis Children's Hospital
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerry R. Mendell, Director, Center for Gene Therapy, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01982695     History of Changes
Other Study ID Numbers: IRB12-00149
First Submitted: October 29, 2013
First Posted: November 13, 2013
Results First Submitted: August 14, 2015
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017
Last Verified: January 2017

Keywords provided by Jerry R. Mendell, Nationwide Children's Hospital:
Duchenne muscular Dystrophy (DMD)
Cardiomyopathy
Losartan
Lisinopril

Additional relevant MeSH terms:
Cardiomyopathies
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Heart Diseases
Cardiovascular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Losartan
Lisinopril
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs