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Cell Therapy in Dilated Cardiomyopathy: Observational Study

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ClinicalTrials.gov 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

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
Primary Completion Date : August 2006
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, Senior)
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 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

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

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

Responsible Party: Helena Martino, Brazil: National Institute of Cardioloy
ClinicalTrials.gov Identifier: NCT00612911     History of Changes
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:
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases