Status:
TERMINATED
Cell Therapy in Dilated Cardiomyopathy: Observational Study
Lead Sponsor:
Ministry of Health, Brazil
Conditions:
Cardiomyopathy, Dilated
Eligibility:
All Genders
18-70 years
Brief Summary
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy
Detailed Description
Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction \<35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arter...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic dilated cardiomyopathy
- Optimized therapy and for idiopathic dilated cardiomyopathy
- Left ventricular ejection fraction (Simpson) \< 35%
- Peak oxygen consumption (VO2 peak) \< 16 mL.kg-1min-1
- Functional classes II-IV of the NYHA
Exclusion
- dilated cardiopathies of ischemic or chagasic origin
- primary valve disease
- excessive use of alcohol or illicit drugs
- pregnancy
- ventricular arrhythmias
- any co-morbidity with impact on survival
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00612911
Start Date
February 1 2005
End Date
August 1 2007
Last Update
February 12 2008
Active Locations (1)
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1
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, Brazil, 22.240-006