Syndecan-4 as a Biomarker in Patients With Chagas Disease
|ClinicalTrials.gov Identifier: NCT01842867|
Recruitment Status : Completed
First Posted : April 30, 2013
Last Update Posted : October 12, 2015
|Condition or disease|
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;
- Holter Electrocardiogram;
- 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 Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Patients with Chagas disease diagnosis
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.
- 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
- 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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842867
|Hospital São Rafael|
|Salvador, Bahia, Brazil, 41253-190|
|Principal Investigator:||Milena Botelho Pereira Soares, PhD||Hospital São Rafael|
|Study Director:||Ricardo Ribeiro dos Santos, MD||Hospital São Rafael|
|Study Chair:||Ticiana Ferreira Larocca, MD||Hospital São Rafael|
|Study Chair:||Márcia Maria Noya Rabelo, MD||Hospital São Rafael|
|Study Chair:||Luís Cláudio Lemos Correia, MD||Hospital São Rafael|
|Study Chair:||Bruno Solano de Freitas Souza, MD||Hospital São Rafael|
|Study Chair:||Carolina Thé Macedo, MD||Hospital São Rafael|