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Cell Therapy in Dilated Cardiomyopathy: Observational Study

This study has been terminated.
(finish study as protocol)
Sponsor:
Information provided by:
Ministry of Health, Brazil
ClinicalTrials.gov Identifier:
NCT00612911
First received: January 23, 2008
Last updated: January 29, 2008
Last verified: January 2008
History of Changes
  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:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

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

Primary Outcome Measures:
  • echocardiography [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Helena Martino, Brazil: National Institute of Cardioloy
ClinicalTrials.gov Identifier: NCT00612911     History of Changes
Other Study ID Numbers: CTDil-1
Study First Received: January 23, 2008
Last Updated: January 29, 2008
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on May 21, 2013