Evaluation of G-CSF treatment of patients with chagasic cardiomyopathy.

Phase 2

• Conditions: C03.752.300.900.200.190; B57.2; chronic cardiac failure secondary to Chagas Disease, in functional classes II, III and IV

• Registration Number: RBR-6tnw2b
• Lead Sponsor: Fundação Oswaldo Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies; Diagnosis of Chagas' cardiomyopathy in functional classes II, III and NYHA IV heart failure; Availability and willingness to participate, given the schedule of the study; Agreement and signing the consent form.

Exclusion Criteria

-Acute systemic infections; Solid Malignancies, myelodysplasia, acute myeloid leukemia or chronic, confirmed by imaging studies or past medical history; Valvular with hemodynamic consequences;
Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history; Renal dysfunction, severe liver or thyroid, confirmed by imaging studies or past medical history;
Pregnancy (confirmed by examination of ? HCG) or lactation; Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.

Study & Design

• Study Type: Intervention
• Study Design: Not specified