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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00612911
Other study ID # CTDil-1
Secondary ID
Status Terminated
Phase N/A
First received January 23, 2008
Last updated January 29, 2008
Start date February 2005
Est. completion date August 2007

Study information

Verified date January 2008
Source Ministry of Health, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Observational

Clinical Trial Summary

Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy


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 arteries and followed for 6 months


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date August 2007
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Cell therapy
bone marrow mononuclear cell

Locations

Country Name City State
Brazil INCL - National Institute of Cardiology Laranjeiras Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary echocardiography 2 months No
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