Clinical Trial: Cell Therapy In Dilated Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy

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

Detailed Summary:

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.


Sponsor: Ministry of Health, Brazil

Current Primary Outcome: increase of the ejection fraction of the left ventricle [ Time Frame: 6 months ]

Original Primary Outcome: increase of the ejection fraction of the left ventricle

Current Secondary Outcome:

  • Death by any cause [ Time Frame: 1 year ]
  • Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline [ Time Frame: 1 year ]
  • Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire [ Time Frame: 6 month ]
  • Difference in NYHA functional class [ Time Frame: 6 month ]
  • Percent number of patients that reached an absolute increase of 5% in ejection fraction [ Time Frame: 1 year ]


Original Secondary Outcome:

  • 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


Information By: Ministry of Health, Brazil

Dates:
Date Received: June 5, 2006
Date Started: January 2006
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017