Cell Therapy In Dilated Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Ministry of Health, Brazil.
Recruitment status was  Recruiting
Financiadora de Estudos e Projetos
Information provided by:
Ministry of Health, Brazil
ClinicalTrials.gov Identifier:
First received: June 5, 2006
Last updated: November 19, 2008
Last verified: June 2006
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Condition Intervention Phase
Dilated Cardiomyopathy
Procedure: Stem cell
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy

Resource links provided by NLM:

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

Primary Outcome Measures:
  • increase of the ejection fraction of the left ventricle [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death by any cause [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Difference in NYHA functional class [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Percent number of patients that reached an absolute increase of 5% in ejection fraction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2006
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.

The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of dilated cardiomyopathy according to WHO criteria
  • Syndromic heart failure in functional class III or IV of the NYHA
  • Enrollment and continuous follow-up in cardiac out-patient clinic
  • Adequate medical therapy after optimization therapy
  • Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

Exclusion Criteria:

  • Valvular diseases, except functional mitral or tricuspid reflow
  • Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
  • Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
  • Sustained ventricular tachycardia
  • Abusive use of alcohol or illicit drugs
  • Pregnancy
  • Use of cardio toxic drugs
  • Any co-morbidity with impact in life expectancy in 2 years
  • Renal function compromised (creatinine above 2 mg/dl)
  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: NCT00333827

Contact: Antonio Carlos C de Carvalho, MD,PhD +5521-22055422 acarlos@biof.ufrj.br
Contact: Bernardo R Tura, MD,MsC +5521-22055422 tura@centroin.com.br

INCL - National Institute of Cardiology Laranjeiras Recruiting
Rio de Janeiro, Brazil, 22.240-006
Contact: Augsuto Z Bozza, MD    +5521-2285-3344 ext 2288    abozza@cardiol.br   
Contact: Helena F Martinho, MD    +5521-2285-3344 ext 2288    hfmartino@alternex.com.br   
Sub-Investigator: Helena F Martino, MD         
Sponsors and Collaborators
Ministry of Health, Brazil
Financiadora de Estudos e Projetos
Study Director: Antonio Carlos C de Carvalho, MD,PhD INCL
Study Chair: Bernardo R Tura, Md,MsC INCL
Principal Investigator: Augusto Z Bozza, MD INCL
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00333827     History of Changes
Other Study ID Numbers: EMRTCC-MCD 
Study First Received: June 5, 2006
Last Updated: November 19, 2008
Health Authority: Brazil: Ministry of Health

Keywords provided by Ministry of Health, Brazil:
Dilated Cardiomyopathy
stem cells
Randomized Controlled Trials

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

ClinicalTrials.gov processed this record on May 26, 2016