Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial
1 other identifier
interventional
76
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2009
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedMay 4, 2015
April 1, 2015
3 years
March 24, 2015
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy
Progression of myocardial fibrosis
2 years
Secondary Outcomes (1)
Specific genetic mutations as predictors of cardiac involvement
2 years
Study Arms (2)
ACE inhibitor
EXPERIMENTALACE 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.
Control
NO INTERVENTIONPatients with preserved EF (LVEF grater than 50%) and with no detectable delayed enhancement (myocardial fibrosis) in cardiac magnetic resonance
Interventions
Eligibility Criteria
You may qualify if:
- Patients with biopsy-proven Muscular Dystrophy of Duchenne or Becker
You may not qualify if:
- Contraindications to cardiovascular magnetic resonance imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InCor Heart Institutelead
- Federal University of Minas Geraiscollaborator
- University of Sao Paulocollaborator
Related Publications (1)
Silva MC, Magalhaes TA, Meira ZM, Rassi CH, Andrade AC, Gutierrez PS, Azevedo CF, Gurgel-Giannetti J, Vainzof M, Zatz M, Kalil-Filho R, Rochitte CE. Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy: A Randomized Clinical Trial. JAMA Cardiol. 2017 Feb 1;2(2):190-199. doi: 10.1001/jamacardio.2016.4801.
PMID: 27926769DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos E Rochitte, MD, PhD
InCor, Heart Institute, University of Sao Paulo Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Cardiology
Study Record Dates
First Submitted
March 24, 2015
First Posted
May 4, 2015
Study Start
June 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
May 4, 2015
Record last verified: 2015-04