Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy (NCT02154269) | Clinical Trial Compass
CompletedPhase 2
Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy
Brazil70 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range20 Years – 70 Years
SexALL
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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.
What they're measuring
1
NYHA (New York Heart Association) functional class improvement
Timeframe: 6, 9 and 12 months after the therapy with G-CSF