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