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Galectin-3 as a Biomarker in Patients With Chagas Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hospital Sao Rafael
Sponsor:
Information provided by (Responsible Party):
Milena Botelho Pereira Soares, Hospital Sao Rafael
ClinicalTrials.gov Identifier:
NCT01842854
First received: April 18, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition
Chagas Disease.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease

Resource links provided by NLM:


Further study details as provided by Hospital Sao Rafael:

Primary Outcome Measures:
  • Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging


Secondary Outcome Measures:
  • Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mensuration of the functional capacity with treadmill test

  • Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Correlation of plasmatic levels of Galectin-3 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


Estimated Enrollment: 60
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)
Groups/Cohorts
Patients with Chagas disease diagnosis
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

Detailed 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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tertiary Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842854

Contacts
Contact: Milena Botelho Pereira Soares, PhD +557132816455 milenabpsoares@gmail.com

Locations
Brazil
Hospital São Rafael Recruiting
Salvador, Bahia, Brazil, 41253-190
Contact: Milena Soares, PhD    +557132816455    milenabpsoares@gmail.com   
Principal Investigator: Milena Botelho Pereira Soares, PhD         
Sponsors and Collaborators
Hospital Sao Rafael
Investigators
Principal Investigator: Milena Botelho Pereira Soares, PhD Hospital São Rafael
Study Director: Ricardo Ribeiro dos Santos, MD, PhD Hospital São Rafael
Study Chair: Ticiana Ferreira Larocca, MD, MSC Hospital São Rafael
Study Chair: Márcia Maria Noya Rabelo, MD, MSC Hospital São Rafael
Study Chair: Luís Cláudio Lemos Correia, MD, PhD Hospital São Rafael
Study Chair: Bruno Solano de Freitas Souza, MD, MSC Hospital São Rafael
Study Chair: Carolina Thé Macedo, MD Hospital São Rafael
  More Information

No publications provided

Responsible Party: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT01842854     History of Changes
Other Study ID Numbers: CEP-41-10, Galectin-Chagas
Study First Received: April 18, 2013
Last Updated: April 25, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Sao Rafael:
Galectin-3
Chagas disease
Biomarkers

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Trypanosomiasis

ClinicalTrials.gov processed this record on November 25, 2014