Status:
UNKNOWN
The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy
Lead Sponsor:
Suzuka Hospital
Collaborating Sponsors:
Nagoya University
Conditions:
Duchenne Muscular Dystrophy
Cardiomyopathies
Eligibility:
MALE
8-45 years
Phase:
PHASE4
Brief Summary
Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The purpose of this...
Detailed Description
The life span in patients with Duchenne muscular dystrophy has been extending due to the development of artificial respiratory devices. According to that, the ratio of cardiac dysfunction as a cause o...
Eligibility Criteria
Inclusion
- Male patients with Duchenne muscular dystrophy are required to meet the following criteria:
- Aged ８ to 45 years
- Positive plasma cardiac troponin I (0.06ng/mL) at least 4 blood measurement in every 3 month.
- Left ventricular ejection fraction \>30% by echocardiography assessment
- Written informed consent
Exclusion
- Patients with the following conditions will be excluded from the study:
- Left ventricular ejection fraction \<30%
- No plasma cTnI elevation
- beta-blocker is already administered without measurement of plasma cTnI
- Contraindication against treatment with β blockers
- Any other serious disease that could potentially complicate the management and follow-up protocols
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00606775
Start Date
December 1 2007
End Date
December 1 2012
Last Update
February 5 2008
Active Locations (1)
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1
Suzuka Hospial
Suzuka, Mie-ken, Japan, 513-8501