Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial
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|ClinicalTrials.gov Identifier: NCT02432885|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : May 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Fibrosis Muscular Dystrophies||Drug: Enalapril||Phase 3|
Duchenne and Becker muscular dystrophies (DMD/BMD) are diseases characterized by progressive skeletal muscle degeneration and replacement by fibrofatty tissue. Data on cardiac involvement (defined as myocardial fibrosis), effect of ACE-inhibitors and specific genetic mutations on myocardial involvement detected by cardiac magnetic resonance (CMR) is lacking.
The study will include 76 patients with DMD/BMD. All patients will be referred to two CMRs for assessment of ventricular function and myocardial fibrosis. Patients with myocardial fibrosis and normal left ventricle ejection fraction (LVEF) will be randomized into two groups, each group receiving ACE-inhibitor treatment or no treatment for cardiomyopathy. A genetic profile will be performed in every patient to identify possible mutations related to cardiac involvement.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - Angiotensin-Converting-Enzyme (ACE) Inhibitor Therapy|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2013|
Experimental: ACE inhibitor
ACE inhibitor (enalapril up to 20mg BID), in patients with preserved EF (LVEF grater than 50%) and with detectable delayed enhancement (myocardial fibrosis) in cardiac magnetic resonance, randomized to therapy or not.
up to 20mg bid
No Intervention: Control
Patients with preserved EF (LVEF grater than 50%) and with no detectable delayed enhancement (myocardial fibrosis) in cardiac magnetic resonance
- Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy [ Time Frame: 2 years ]Progression of myocardial fibrosis
- Specific genetic mutations as predictors of cardiac involvement [ Time Frame: 2 years ]Relation of dystrophin gene site mutations in exons <45 relation and the extent of myocardial fibrosis measured by cardiac magnetic resonance
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): NCT02432885
|Principal Investigator:||Carlos E Rochitte, MD, PhD||InCor, Heart Institute, University of Sao Paulo Medical School|