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MicroRNAs as Biomarkers in Patients With Chagas Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01842880
Enrollment
60
Registered
2013-04-30
Start date
2011-01-31
Completion date
2013-12-31
Last updated
2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease

Keywords

MicroRNAs, Chagas disease, Biomarkers

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).

Interventions

None listed

Sponsors

Hospital Sao Rafael
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosisOne yearMensuration of heart fibrosis percentage with Magnetic Resonance Imaging

Secondary

MeasureTime frameDescription
Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacityOne yearMensuration of the functional capacity with treadmill test.
Correlation of plasmatic levels of MicroRNAs with the left ventricular functionOne yearMensuration 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 TNF-alphaOne year
Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.One year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026