MicroRNAs as Biomarkers in Patients With Chagas Disease

Completed

• Conditions: Chagas Disease

• Registration Number: NCT01842880
• Lead Sponsor: Hospital Sao Rafael

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-30
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis	One year	Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging

Secondary Outcome Measures

Name	Time	Method
Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity	One year	Mensuration of the functional capacity with treadmill test.
Correlation of plasmatic levels of MicroRNAs with the left ventricular function	One year	Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging
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 IFN-gamma.	One year
Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha	One year

Trial Locations

Locations (1)

Hospital São Rafael; 🇧🇷 Salvador, Bahia, Brazil