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

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Sao Rafael
• Treatments: Lenograstim; Sargramostim

Criteria

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.