Chronic Chagasic Myocarditis
Conditions
Keywords
Chagas disease, G-CSF, Cell therapy
Brief 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.
Interventions
DRUGTreatment with G-CSF (Granulocyte colony stimulating factor)
Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
DRUGPlacebo saline
Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.
Sponsors
Hospital Sao Rafael
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NYHA (New York Heart Association) functional class improvement | 6, 9 and 12 months after the therapy with G-CSF | All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of improvement of quality of life | 6 and 12 months after the therapy | All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months. |
| Assessment of cardiovascular function measured by transthoracic echocardiography | 6 and 12 months after the therapy | All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function. |
| Assessment of cardiovascular function measured by cardiac magnetic resonance imaging | 12 months after therapy | All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction. |
| Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test | 12 months after the therapy | All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity. |
| Determination of tolerability | 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy | All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection. |
Countries
Brazil
Outcome results
None listed