Galectin-3 as a Biomarker in Patients With Chagas Disease

Chagas Disease Clinical Trial

Official title:

Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842854
• Other study ID #: CEP-41-10
• Secondary ID: Galectin-Chagas
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: November 27, 2017
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: November 2017
• Source: Hospital Sao Rafael
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to analyze the efficacy of Galectin-3 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.

Description:

Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. Its plasmatic levels are increased on patients with acute decompensated heart failure. These observations suggest that measuring levels of Galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. To investigate the role of this new biomarker in Chagas Disease, we will study a Chagas Disease population (including patients with the indeterminate and cardiac form of the disease). The assessment of the prognostic value of Galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chagas Disease diagnosis confirmed by 2 different serologies

• Diagnosis of indeterminate form or cardiac form, with and without ventricular dysfunction.

Exclusion Criteria:

• 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

• Severe or moderate 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

Related Conditions & MeSH terms

• Chagas Disease

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Rafael

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis	Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging	One year
Secondary	Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart	Mensuration of the functional capacity with treadmill test	One year
Secondary	Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.		One year
Secondary	Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha		One year
Secondary	Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.		One year