Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

Official Title
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Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy

Conditions
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Chronic Chagasic Myocarditis

Intervention / Treatment
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* Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)
* Drug: Placebo saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies; Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure; Availability and willingness to participate, given the schedule of the study; Agreement and signing the written form. Exclusion Criteria: Acute systemic infections Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history; Valvulopathies with hemodynamic consequences; Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history; Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history; Pregnancy (confirmed by examination of β HCG) or lactation; Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF<br>Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles. | Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)<br>* Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.<br>* Other names: G-CSF;|
| Placebo Comparator: Saline<br>Subjects will be randomly assigned to receive saline for five days, during 4 cicles. | Drug: Placebo saline<br>* Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA (New York Heart Association) functional class improvement | All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure. | 6, 9 and 12 months after the therapy with G-CSF | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of cardiovascular function measured by transthoracic echocardiography | All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function. | 6 and 12 months after the therapy | 
| Assessment of cardiovascular function measured by cardiac magnetic resonance imaging | All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction. | 12 months after therapy | 
| Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test | All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity. | 12 months after the therapy | 
| Evaluation of improvement of quality of life | All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months. | 6 and 12 months after the therapy | 
| Determination of tolerability | All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection. | 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chagas disease, G-CSF, Cell therapy