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Cell Therapy in Dilated Cardiomyopathy: Observational Study

This study has been terminated.
(finish study as protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612911
First Posted: February 12, 2008
Last Update Posted: February 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ministry of Health, Brazil
  Purpose
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Condition Intervention
Cardiomyopathy, Dilated Other: Cell therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Brazil:

Primary Outcome Measures:
  • echocardiography [ Time Frame: 2 months ]

Enrollment: 24
Study Start Date: February 2005
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Major group
Patients with Idiopathic dilated cardiomyopathy
Other: Cell therapy
bone marrow mononuclear cell

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 arteries and followed for 6 months
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic dilated cardiomyopathy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612911


Locations
Brazil
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Brazil, 22.240-006
Sponsors and Collaborators
Ministry of Health, Brazil
Investigators
Principal Investigator: Helena F Martino Brazil: National Insittute of Cardiology
  More Information

Responsible Party: Helena Martino, Brazil: National Institute of Cardioloy
ClinicalTrials.gov Identifier: NCT00612911     History of Changes
Other Study ID Numbers: CTDil-1
First Submitted: January 23, 2008
First Posted: February 12, 2008
Last Update Posted: February 12, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly