Clinical Trial: Galectin-3 as a Biomarker in Patients With Chagas Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease

Brief Summary: The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker 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 Summary:

Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. Its plasmatic levels are increased on patients with acute decompensated heart failure. These observations suggest that measuring levels of Galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. To investigate the role of this new biomarker in Chagas Disease, we will study a Chagas Disease population (including patients with the indeterminate and cardiac form of the disease). The assessment of the prognostic value of Galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests.

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).

Sponsor: Hospital Sao Rafael

Current Primary Outcome: Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis [ Time Frame: One year ]

Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart [ Time Frame: One year ]
    Mensuration of the functional capacity with treadmill test
  • Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP. [ Time Frame: One year ]
  • Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha [ Time Frame: One year ]
  • Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma. [ Time Frame: One year ]


Original Secondary Outcome: Same as current

Information By: Hospital Sao Rafael

Dates:
Date Received: April 18, 2013
Date Started: January 2011
Date Completion:
Last Updated: October 9, 2015
Last Verified: October 2015