- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842854
Galectin-3 as a Biomarker in Patients With Chagas Disease
Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bahia
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Salvador, Bahia, Brazil, 41253-190
- Hospital Sao Rafael
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis
Time Frame: One year
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Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One year
|
Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.
Time Frame: One year
|
One year
|
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Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha
Time Frame: One year
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One year
|
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Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
- Study Director: Ricardo Ribeiro dos Santos, MD, PhD, Hospital Sao Rafael
- Study Chair: Ticiana Ferreira Larocca, MD, MSC, Hospital Sao Rafael
- Study Chair: Márcia Maria Noya Rabelo, MD, MSC, Hospital Sao Rafael
- Study Chair: Luís Cláudio Lemos Correia, MD, PhD, Hospital Sao Rafael
- Study Chair: Bruno Solano de Freitas Souza, MD, MSC, Hospital Sao Rafael
- Study Chair: Carolina Thé Macedo, MD, Hospital Sao Rafael
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-41-10
- Galectin-Chagas (Registry Identifier: CEP HSR 41-10)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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