Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Study Overview
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Brief Summary
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The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.

Detailed Description
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The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. Some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive). The objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with Chagas disease. The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5. The patients shall be accompanied in the specialized outpatient clinics for Chagas disease - Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.

Official Title
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Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Conditions
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Chagas Disease

Intervention / Treatment
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* Genetic: Gathering of samples of genetic material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chagas disease diagnosis confirmed by 2 different serologies Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction Exclusion Criteria: Significant aortic stenosis Mitral stenosis with a valve area inferior than 1,5 cm2 Superior or moderated aortic and/or mitral regurgitation Chronic use of immunosuppressive agents Dialysis treatment of terminal renal failure Fever on the last 48 hours or evidence of systemic infection in activity Current abusive use of alcohol or illicit drugs Any other comorbidities that impact patient's survival within the next 2 years Liver disease in activity Continuous use of steroids as treatment for chronic obstructive pulmonary disease Hematologic, neoplastic or bone diseases Homeostasis disturbances Inflammatory diseases or chronic infectious diseases

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group<br>Group which contains all the patients of the study. | Genetic: Gathering of samples of genetic material<br>* The samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease | We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease. | The outcome measure will be assessed within one month of follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis | We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis assessed by magnetic resonance. | The outcome measure will be assessed within one month of follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chagas disease, Polymorphisms, Biomarkers