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
Sponsor:
Collaborator:
FINEP - Financiadora de Estudos e Projetos
Information provided by:
Ministry of Health, Brazil
ClinicalTrials.gov Identifier:
NCT00333827
First received: June 5, 2006
Last updated: November 19, 2008
Last verified: June 2006

June 5, 2006
November 19, 2008
January 2006
December 2008   (final data collection date for primary outcome measure)
increase of the ejection fraction of the left ventricle [ Time Frame: 6 months ] [ Designated as safety issue: No ]
increase of the ejection fraction of the left ventricle
Complete list of historical versions of study NCT00333827 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Death by any cause within 1 year of intervention
  • Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline
  • Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
  • Difference in NYHA functional class at six months and baseline
  • Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Not Provided
Not Provided
 
Cell Therapy In Dilated Cardiomyopathy
Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dilated Cardiomyopathy
Procedure: Stem cell
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2009
December 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
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
Brazil
 
NCT00333827
EMRTCC-MCD
Not Provided
Not Provided
Ministry of Health, Brazil
FINEP - 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
Ministry of Health, Brazil
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP