Colchicine for Patients With Chagas´ Disease( B1 Stage)

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease

Conditions
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Chagas Disease, Colchicine Resistance

Intervention / Treatment
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* Drug: Colchicine 0.5 MG twice day for one year
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and serological diagnosis of Chagas´disease ( Stage B1) Must be able to swallow tablets Exclusion Criteria: myocardial infarction or coronary artery disease, diabetes mellitus, valvular disease, creatinine clearance <30 ml / kg / min contraindication to perform cardiac magnetic resonance imaging use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers previous use of benzonidazole

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colchicine<br>colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year | Drug: Colchicine 0.5 MG twice day for one year<br>* placebo twice day for one year<br>* Other names: placebo oral tablet;|
| Active Comparator: placebo<br>placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet | Drug: Placebo Oral Tablet<br>* placebo twice day for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrosis, Inflammation