Cell Therapy in Dilated Cardiomyopathy: Observational Study

NCT ID: NCT00612911

Last Updated: 2008-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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

Conditions

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Cardiomyopathy, Dilated

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Major group

Patients with Idiopathic dilated cardiomyopathy

Cell therapy

Intervention Type OTHER

bone marrow mononuclear cell

Interventions

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Cell therapy

bone marrow mononuclear cell

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Brazil: National Institute of Cardioloy

Principal Investigators

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Helena F Martino

Role: PRINCIPAL_INVESTIGATOR

Brazil: National Insittute of Cardiology

Locations

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INCL - National Institute of Cardiology Laranjeiras

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CTDil-1

Identifier Type: -

Identifier Source: org_study_id

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