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
  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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014