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Galectin-3 as a Biomarker in Patients With Chagas Disease

NCT ID: NCT01842854

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Chagas Disease

Keywords

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Galectin-3 Chagas disease Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Chagas disease diagnosis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Rafael

OTHER

Sponsor Role lead

Responsible Party

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Milena Botelho Pereira Soares

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milena Botelho Pereira Soares, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Rafael

Ricardo Ribeiro dos Santos, MD, PhD

Role: STUDY_DIRECTOR

Hospital São Rafael

Ticiana Ferreira Larocca, MD, MSC

Role: STUDY_CHAIR

Hospital São Rafael

Márcia Maria Noya Rabelo, MD, MSC

Role: STUDY_CHAIR

Hospital São Rafael

Luís Cláudio Lemos Correia, MD, PhD

Role: STUDY_CHAIR

Hospital São Rafael

Bruno Solano de Freitas Souza, MD, MSC

Role: STUDY_CHAIR

Hospital São Rafael

Carolina Thé Macedo, MD

Role: STUDY_CHAIR

Hospital São Rafael

Locations

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Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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Noya-Rabelo MM, Larocca TF, Macedo CT, Torreao JA, Souza BS, Vasconcelos JF, Souza LE, Silva AM, Ribeiro Dos Santos R, Correia LC, Soares MB. Evaluation of Galectin-3 as a Novel Biomarker for Chagas Cardiomyopathy. Cardiology. 2017;136(1):33-39. doi: 10.1159/000447529. Epub 2016 Aug 23.

Reference Type DERIVED
PMID: 27548475 (View on PubMed)

Other Identifiers

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Galectin-Chagas

Identifier Type: REGISTRY

Identifier Source: secondary_id

CEP-41-10

Identifier Type: -

Identifier Source: org_study_id