Status:
TERMINATED
Cell Therapy in Chagas Cardiomyopathy
Lead Sponsor:
Ministry of Health, Brazil
Collaborating Sponsors:
Financiadora de Estudos e Projetos
Conditions:
Chagas Cardiomyopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 cardiomyop...
Eligibility Criteria
Inclusion
- 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
- 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)
- Definitive implant of pace-makers, resynchronizers and CDIs
- Heart failure with symptoms initiating less than 1 year ago
- Active systemic arterial hypertension or history of hypertension
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00349271
Start Date
January 1 2006
End Date
December 1 2011
Last Update
March 13 2017
Active Locations (1)
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1
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, Brazil, 22.240-006