Viewing Study NCT01842867


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Study NCT ID: NCT01842867
Status: COMPLETED
Last Update Posted: 2015-10-12
First Post: 2013-04-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Syndecan-4 as a Biomarker in Patients With Chagas Disease
Sponsor: Hospital Sao Rafael
Organization:

Study Overview

Official Title: Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.
Status: COMPLETED
Status Verified Date: 2015-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Description: 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).

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: