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临床试验/NCT02646943
NCT02646943已完成不适用

Longitudinal Study of Patients With Chronic Chagas Cardiomyopathy in Brazil (SaMi_Trop Project)

University of Sao Paulo0 个研究点目标入组 1,959 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,959
主要终点
Death

研究概览

简要总结

BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world, with 8-10 million infected people and only one marginally effective therapeutic. The lack of good biomarkers for active infection or clinical end-points poses a problem for assessing the performance of new drugs or therapeutic interventions. Among the biomarkers, several studies showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular systolic and diastolic dysfunction.

OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma cruzi infection with the goal of finding an array of biomarkers that correlate with parasite persistence and Chagas cardiac disease status that can be used to infer risk of disease progression and death as well used as markers of cure (parasite eradication) or clinical efficacy (stabilize or reverse cardiac damage) of novel drugs

METHOD: The investigators established a prospective cohort of 1,959 patients with chronic Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and 24 months) . The evaluation included collection of socio-demographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life, blood sample collection and ECG.

详细描述

RESEARCH STRATEGY

SIGNIFICANCE

The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) consists of a network of collaborating scientists in the States of Minas Gerais and São Paulo which has been established for the purpose of developing and conducting research projects on neglected infectious diseases in Brazil, with an initial focus on Chagas Disease biomarker, discovery and validation. The SaMi-Trop represents a major challenge for focused research in neglected diseases, with knowledge that can be applied in primary health care.

Chronic Chagas Cardiomyopathy (CCC) is the most important clinical presentation of Chagas Disease (ChD), eventually affecting approximately 20% to 30% of those in the chronic phase of the disease. CCC comprises a wide range of manifestations, including heart failure, arrhythmias, heart-blocks, sudden death, thromboembolism and stroke [1]. Clinical presentation typically varies widely according to the degree of myocardial damage and most patients present a mild form of heart disease, frequently characterized only by the presence of asymptomatic abnormalities on the ECG or in other complimentary exams [2]. Nonetheless, when heart failure and/or severe arrhythmias manifest, the prognosis is ominous, with high and premature mortality rates, typically in adult male patients,1 but also in the elderly [3]. Indeed, when compared to patients with idiopathic cardiomyopathy, patients with CCC have poorer survival, irrespective of other clinical and echocardiographic parameters [4].

Thus, the clinical course of Chagas heart disease is variable and identifying patients who are at risk of progressive CCC and dying remains a challenge. Several longitudinal studies performed in patients in the chronic phase of ChD demonstrated that many individual characteristics predict an unfavorable prognosis. This subject was systematically reviewed a few years ago and concluded that most studies were described in insufficient detail and/or lacked minimal standards in reporting results. Results have been somewhat inconsistent in different studies, and the best combination of clinical and laboratory variables predictive of mortality has not yet been established [5].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • The exclusion criteria include pregnancy or breast feeding, and any severe condition with ominous prognosis that indicates a life expectancy of less than two years.

结局指标

主要结局

Death

时间窗: 24 months

次要结局

  • Hospitalization due to cardiovascular(baseline and 24 months)
  • Changes in the ECG pattern(baseline and 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ester Cerdeira Sabino

Associate Professor

University of Sao Paulo

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