Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chagas Disease diagnosis confirmed by 2 different serologies
- •Diagnosis of indeterminate form or cardiac form, with and without ventricular dysfunction.
排除标准
- •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
结局指标
主要结局
Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis
时间窗: One year
Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
次要结局
- Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart(One year)
- Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.(One year)
- Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha(One year)
- Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.(One year)
研究者
Milena Botelho Pereira Soares
PhD
Hospital Sao Rafael