chronic cardiac failure secondary to Chagas Disease, in functional classes II, III and IV
Conditions
Interventions
Patients diagnosed with Chagas Disease, between 20 to 70 years of age, will be divided into two random groups, the experimental group, including 35 patients which will be administered with G-CSF injec
Drug
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Age
20 Years to 70 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of improvement of NYHA functional class during the 6, 9 and 12 months after institution of therapy with G-CS. That in the control group, there is improvement in functional class in 10% of patients are expected. In the experimental group, is expected to improve this parameter in 40% of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of cardiovascular function measured by transthoracic echocardiography. which will be considered related to therapy improves with GCS-F when there is increase of at least 10% ejection fraction on echocardiogram results. | — |
Countries
Brazil
Contacts
Public ContactMilena ;Ticiana Soares.;Larocca
Centro de Biotecnologia e Terapia Celular;Centro de Biotecnologia e Terapia Celular
Outcome results
None listed