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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 May 2015 |
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Main ID: |
NCT02432885 |
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Date of registration:
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24/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial
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Scientific title:
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Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - Angiotensin-Converting-Enzyme (ACE) Inhibitor Therapy |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02432885 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Carlos E Rochitte, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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InCor, Heart Institute, University of Sao Paulo Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with biopsy-proven Muscular Dystrophy of Duchenne or Becker
Exclusion Criteria:
- Contraindications to cardiovascular magnetic resonance imaging
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Muscular Dystrophies
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Myocardial Fibrosis
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Intervention(s)
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Drug: Enalapril
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Primary Outcome(s)
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Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy
[Time Frame: 2 years]
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Secondary Outcome(s)
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Specific genetic mutations as predictors of cardiac involvement
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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