MicroRNAs as Biomarkers in Patients With Chagas Disease

Study Overview
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Brief Summary
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The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

Detailed Description
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The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including: Collection of Blood samples for biochemical analysis; Electrocardiogram; Holter Electrocardiogram; Echocardiogram; Treadmill Test; X-Ray Imaging; Magnetic Resonance Imaging; Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).

Official Title
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Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease

Conditions
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Chagas Disease

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 valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg Mitral stenosis with a valve area inferior than 1,5 cm2 Severe or moderate 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 according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine) Current abusive use of alcohol or illicit drugs (Based on the DSM IV) Any other comorbidities that impact patient's survival within the next 2 years Liver disease in activity Continuous use of steroids as treatment for COPD 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 |
| --- | --- |
| Patients with Chagas disease diagnosis<br>Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis | Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity | Mensuration of the functional capacity with treadmill test. | One year | 
| Correlation of plasmatic levels of MicroRNAs with the left ventricular function | Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging | One year | 
| Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP. |  | One year | 
| Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha |  | One year | 
| Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma. |  | One year | 

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