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Completed

NCT Number: NCT01842880

MicroRNAs as Biomarkers in Patients With Chagas Disease

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis

    Time frame: One year

    Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging

Secondary outcomes

  1. Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity

    Time frame: One year

    Mensuration of the functional capacity with treadmill test.

  2. Correlation of plasmatic levels of MicroRNAs with the left ventricular function

    Time frame: One year

    Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging

  3. Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP.

    Time frame: One year

  4. Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha

    Time frame: One year

  5. Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Hospital Sao Rafael

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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