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

Hospital Sao Rafael

Status and phase: Completed; Phase 2

Conditions: Chronic Chagasic Myocarditis

Treatments: Drug: Treatment with G-CSF (Granulocyte colony stimulating factor); Drug: Placebo saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02154269

PCL07/12

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

G-CSF

Experimental group

Description:

Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.

Treatment:

Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)

Saline

Placebo Comparator group

Description:

Subjects will be randomly assigned to receive saline for five days, during 4 cicles.

Treatment:

Drug: Placebo saline