Syndecan-4 as a Biomarker in Patients With Chagas Disease
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.|
- Correlation of plasmatic levels of syndecan-4 with the percentage of heart fibrosis [ Time Frame: One year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Mensuration of the functional capacity with treadmill test.
- Correlation of plasmatic levels of Syndecan-4 with the left ventricular function [ Time Frame: One year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Correlation of plasmatic levels of Syndecan-4 with the serum levels of TNF-alpha [ Time Frame: One year ] [ Designated as safety issue: No ]
- Correlation of plasmatic levels of Syndecan-4 with the serum levels of IFN-gamma. [ Time Frame: One year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Plasma, Serum, Whole Blood
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Patients with Chagas disease diagnosis
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842867
|Contact: Milena Botelho Pereira Soares, PhDfirstname.lastname@example.org|
|Hospital São Rafael||Recruiting|
|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|