Clinical Trial: Syndecan-4 as a Biomarker in Patients With Chagas Disease

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

Official Title: Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.

Brief Summary: The purpose of this study is to analyze the efficacy of syndecan-4 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:

Increased serum levels of syndecan-4 have been correlated to acute myocardial infarction and chronic heart failure, suggesting that this molecule can be an important biomarker in heart diseases. In spite of that, there are no studies that have investigated the role of this molecule in chronic chagasic cardiomyopathy yet.

In this project, our objective is to demonstrate the potential role of syndecan-4 in the prognosis of chronic chagasic cardiomyopathy, seeking a better fitting of the treatment through the identification of patients with the worse prognosis.

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 syndecan-4 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 syndecan-4 with the functional cardiovascular capacity [ Time Frame: One year ]
    Mensuration of the functional capacity with treadmill test.
  • Correlation of plasmatic levels of Syndecan-4 with the left ventricular function [ Time Frame: One year ]
    Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging
  • Correlation of plasmatic levels of Syndecan-4 with the serum levels of Pro-BNP. [ Time Frame: One year ]
  • Correlation of plasmatic levels of Syndecan-4 with the serum levels of TNF-alpha [ Time Frame: One year ]
  • Correlation of plasmatic levels of Syndecan-4 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