Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
研究概览
简要总结
The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.
详细描述
The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. Some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive).
The objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with Chagas disease.
The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5.
The patients shall be accompanied in the specialized outpatient clinics for Chagas disease - Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.
研究设计
- 研究类型
- Observational
- 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 Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction
排除标准
- •Significant aortic stenosis
- •Mitral stenosis with a valve area inferior than 1,5 cm2
- •Superior or moderated 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
- •Current abusive use of alcohol or illicit drugs
- •Any other comorbidities that impact patient's survival within the next 2 years
- •Liver disease in activity
- •Continuous use of steroids as treatment for chronic obstructive pulmonary disease
- •Hematologic, neoplastic or bone diseases
- •Homeostasis disturbances
- •Inflammatory diseases or chronic infectious diseases
结局指标
主要结局
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
时间窗: The outcome measure will be assessed within one month of follow up.
We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease.
次要结局
- Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis(The outcome measure will be assessed within one month of follow up.)
研究者
Milena Botelho Pereira Soares
PhD
Hospital Sao Rafael