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Trial record 85 of 163 for:    Idiopathic Dilated Cardiomyopathy

Cell Therapy in Dilated Cardiomyopathy: Observational Study

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. Identifier: NCT00612911
Recruitment Status : Terminated (finish study as protocol)
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Information provided by:
Ministry of Health, Brazil

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

Condition or disease Intervention/treatment
Cardiomyopathy, Dilated Other: Cell therapy

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

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Study Type : Observational
Actual Enrollment : 24 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2007

Group/Cohort Intervention/treatment
Major group
Patients with Idiopathic dilated cardiomyopathy
Other: Cell therapy
bone marrow mononuclear cell

Primary Outcome Measures :
  1. echocardiography [ Time Frame: 2 months ]

Information from the National Library of Medicine

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

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
  • 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

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 identifier (NCT number): NCT00612911

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

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Responsible Party: Helena Martino, Brazil: National Institute of Cardioloy Identifier: NCT00612911    
Other Study ID Numbers: CTDil-1
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases