Chronic Chagasic Myocarditis Clinical Trial
Official title:
Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy
| NCT number | NCT02154269 |
| Other study ID # | PCL07/12 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | June 2020 |
| Verified date | August 2020 |
| Source | Hospital Sao Rafael |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | June 2020 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 ß HCG) or lactation; - Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital São Rafael | Salvador | Bahia |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Sao Rafael |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NYHA (New York Heart Association) functional class improvement | All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure. | 6, 9 and 12 months after the therapy with G-CSF | |
| Secondary | Assessment of cardiovascular function measured by transthoracic echocardiography | All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function. | 6 and 12 months after the therapy | |
| Secondary | Assessment of cardiovascular function measured by cardiac magnetic resonance imaging | All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction. | 12 months after therapy | |
| Secondary | Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test | All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity. | 12 months after the therapy | |
| Secondary | Evaluation of improvement of quality of life | All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months. | 6 and 12 months after the therapy | |
| Secondary | Determination of tolerability | All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection. | 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy |