Cell Therapy In Dilated Cardiomyopathy

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Brief Title

Cell Therapy In Dilated Cardiomyopathy

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 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

increase of the ejection fraction of the left ventricle

Secondary Outcome

 Death by any cause

Condition

Dilated Cardiomyopathy

Intervention

optimal therapy for cardiaca failure

Study Arms / Comparison Groups

 Optimal Therapy
Description:  Optimal therapy for cardiac failure

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

115

Start Date

January 2006

Completion Date

February 2013

Primary Completion Date

December 2012

Eligibility Criteria

        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)
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Antonio Carlos C de Carvalho, MD,PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT00333827

Organization ID

EMRTCC-MCD


Responsible Party

Principal Investigator

Study Sponsor

Ministry of Health, Brazil

Collaborators

 Financiadora de Estudos e Projetos

Study Sponsor

Antonio Carlos C de Carvalho, MD,PhD, Study Director, INCL


Verification Date

March 2017