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

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

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.

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.