Cell Therapy in Chagas Cardiomyopathy

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

Detailed Description
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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.

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

Conditions
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Chagas Cardiomyopathy

Intervention / Treatment
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* Procedure: Stem cell
* Drug: Filgrastime (G-CSF)
* Drug: Standart therapy


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell therapy<br>Stem Cell therapy | Procedure: Stem cell<br>* Stem cell<br>Drug: Filgrastime (G-CSF)<br>* Filgrastime (G-CSF)<br>|
| Active Comparator: Standart therapy<br>Standart therapy | Drug: Standart therapy<br>* All drug with clinical evidence of benefical effect in Chagas disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of the ejection fraction of the left ventricle |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death by any cause within 1 year of intervention |  | 1 year | 
| Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline |  | 1 year | 
| Difference in NYHA functional class at six months and baseline |  | six months | 
| Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials