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NCT02432885 Clinical Trial

Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial

Muscular Dystrophies Clinical Trial

Official title:
Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - Angiotensin-Converting-Enzyme (ACE) Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02432885
Other study ID # 1095/08
Secondary ID
Status Completed
Phase Phase 3
First received March 24, 2015
Last updated May 1, 2015
Start date June 2009
Est. completion date June 2013

Study information
Verified date April 2015
Source InCor Heart Institute
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

This trial intends to evaluate myocardial Fibrosis progression in Duchenne and Becker Muscular Dystrophy, as well the influence of ACE inhibitors in fibrosis progression. Additionally, this study aims to determine genetic predictors of cardiac involvement in these dystrophies.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date June 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Patients with biopsy-proven Muscular Dystrophy of Duchenne or Becker

Exclusion Criteria:

- Contraindications to cardiovascular magnetic resonance imaging

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Enalapril
up to 20mg bid

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
InCor Heart Institute Federal University of Minas Gerais, University of Sao Paulo

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy Progression of myocardial fibrosis 2 years No
Secondary Specific genetic mutations as predictors of cardiac involvement Relation of dystrophin gene site mutations in exons <45 relation and the extent of myocardial fibrosis measured by cardiac magnetic resonance 2 years No
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