Syndecan-4 as a Biomarker in Patients With Chagas Disease

NCT01842867 | Completed

• 1 other identifier: CEP-41-10-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas Disease

Keywords

Syndecan-4; Chagas disease; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Correlation of plasmatic levels of syndecan-4 with the percentage of heart fibrosis

  Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging

  One year

Secondary Outcomes (5)

• Correlation of plasmatic levels of syndecan-4 with the functional cardiovascular capacity

  One year

• Correlation of plasmatic levels of Syndecan-4 with the left ventricular function

  One year

• Correlation of plasmatic levels of Syndecan-4 with the serum levels of Pro-BNP.

  One year

• Correlation of plasmatic levels of Syndecan-4 with the serum levels of TNF-alpha

  One year

• Correlation of plasmatic levels of Syndecan-4 with the serum levels of IFN-gamma.

  One year

Study Arms (1)

Patients with Chagas disease diagnosis

Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary Hospital

You may qualify if:

• Chagas disease diagnosis confirmed by 2 different serologies
• Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

You may not qualify if:

• Significant valve disease defined as aortic stenosis with a gradient of VE/Ao \> 50 mmHg
• Mitral stenosis with a valve area inferior than 1,5 cm2
• Superior or moderated aortic and/or mitral regurgitation
• Chronic use of immunosuppressive agents
• Dialysis treatment of terminal renal failure
• Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
• Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
• Any other comorbidities that impact patient's survival within the next 2 years
• Liver disease in activity
• Continuous use of steroids as treatment for COPD
• Hematologic, neoplastic or bone diseases
• Homeostasis disturbances
• Inflammatory diseases or chronic infectious diseases

Sponsors & Collaborators

• Hospital Sao Rafael: lead

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Whole Blood

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Milena Botelho Pereira Soares, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• Ricardo Ribeiro dos Santos, MD

  Hospital São Rafael

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 30, 2013
• Study Start: January 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

BR (1)