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Completed

NCT Number: NCT01842854

Galectin-3 as a Biomarker in Patients With Chagas Disease

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis

    Time frame: One year

    Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging

Secondary outcomes

  1. Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart

    Time frame: One year

    Mensuration of the functional capacity with treadmill test

  2. Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.

    Time frame: One year

  3. Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha

    Time frame: One year

  4. Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Hospital Sao Rafael

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2013
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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