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

This study has been completed.
Sponsor:
Collaborators:
Federal University of Minas Gerais
University of Sao Paulo
Information provided by (Responsible Party):
Carlos Eduardo Rochitte, InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT02432885
First received: March 24, 2015
Last updated: May 1, 2015
Last verified: April 2015
  Purpose
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.

Condition Intervention Phase
Myocardial Fibrosis Muscular Dystrophies Drug: Enalapril Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - Angiotensin-Converting-Enzyme (ACE) Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by Carlos Eduardo Rochitte, InCor Heart Institute:

Primary Outcome Measures:
  • Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy [ Time Frame: 2 years ]
    Progression of myocardial fibrosis


Secondary Outcome Measures:
  • 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


Enrollment: 76
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Enalapril
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to cardiovascular magnetic resonance imaging
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02432885

Sponsors and Collaborators
InCor Heart Institute
Federal University of Minas Gerais
University of Sao Paulo
Investigators
Principal Investigator: Carlos E Rochitte, MD, PhD InCor, Heart Institute, University of Sao Paulo Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Eduardo Rochitte, Associate Professor of Cardiology, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT02432885     History of Changes
Other Study ID Numbers: 1095/08
Study First Received: March 24, 2015
Last Updated: May 1, 2015

Keywords provided by Carlos Eduardo Rochitte, InCor Heart Institute:
cardiac magnetic resonance
myocardial fibrosis
muscular dystrophies

Additional relevant MeSH terms:
Fibrosis
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Pathologic Processes
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 18, 2017