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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.
Forty patients will receive colchicine while twenty patients will receive placebo
Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colchicine | Experimental | colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year |
|
| placebo | Active Comparator | placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG twice day for one year | Drug | placebo twice day for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging | myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass | 1 year |
| Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging | myocardial fibrosis quantified in grams or percent of LV mass | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10 | interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL) | 1 year |
| Effect of colchicine on inflammatory marker such as TNF-α |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Fernandes, MD, PHD | Contact | +55 11 2661 5057 | fabio.fernandes@incor.usp.br | |
| Paula Buck, PHD | Contact | +55 11 2661 5346 | carpaula@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Fernandes, Md, PHD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabio Fernandes | Recruiting | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| D005355 | Fibrosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo Oral Tablet | Drug | placebo twice day for one year |
|
TNF-α ELISA (pg/mL) |
| 1 year |
| Effect of colchicine on inflammatory marker such as interferon-gama | Interferon -gama ELISA (pg/mL) | 1 year |
| Effect of colchicine on T Cruzi polymerase chain reaction | 7500 PCR-Real time System (Life Technologies) | 1 year |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |