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临床试验/NCT04445103
NCT04445103终止不适用

The Malaria Heart Disease Study: A Novel Pathway to Subclinical Heart Disease

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2020年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
597
试验地点
1
主要终点
Biomarkers

研究概览

简要总结

The Malaria Heart Disease Study is a prospective longitudinal cohort study of a random sample of approximately 1200 individuals from the state of Acre in Brazil. The overall hypothesis is that patients who have (i) previously suffered from a malaria infection or (ii) patients with ongoing symptomatic malaria will benefit from having an echocardiogram and blood tests performed as a screening tool to diagnose early cardiac impairment and prevent future cardiovascular disease.

详细描述

The purpose of this study is to investigate the relationship between exposure to malaria and the risk of developing subclinical and manifest cardiovascular disease. The study is conducted in the high endemic malaria zone pertaining to the city of Cruzeiro do Sul, located in the state of Acre, Brazil. The city is considered a part of the Amazon basin.

By invitation of a random sample of patients with a history of malaria, controls with no history of malaria, and symptomatic patients with ongoing malaria infection, the aim is to elucidate potential pathways linking malaria to cardiovascular disease.

Aim 1: Determine whether prior exposure to malaria is associated with myocardial dysfunction. The investigators hypothesize that adults with a history of treated malaria (cases) will have worse left ventricular (LV) diastolic function and systolic strain compared to age- and sex-matched controls without a history of malaria infection. The investigators will recruit 500 cases and 500 controls from Cruzeiro-do-Sul, Brazil. State-of-the-art ultrasonographic examinations will be used to asses novel imaging metrics of cardiac function.

Aim 2: Define the extent to which proinflammatory factors (such as Ang-2, CRP, VEGF) are associated with cardiac dysfunction in subjects with a history of malaria. The investigators hypothesize that proinflammatory biomarkers will be higher in cases compared to controls, and that higher concentrations of inflammatory markers will associate with worse LV diastolic function and strain. The investigators will measure inflammatory biomarkers, determine the association with cardiac dysfunction, and test whether history of malaria modifies this association.

Aim 3: Determine if echocardiographic parameters of systolic and diastolic function and cardiac biomarkers are significantly elevated in patients with symptomatic malaria (N=200).

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

  • 未提供

结局指标

主要结局

Biomarkers

时间窗: 2020-2023

Elevated cardiac biomarkers

Echocardiography

时间窗: 2020-2023

Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography

次要结局

  • Inflammation(2020-2023)
  • Endothelial dysfunction(2020-2023)

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Brainin

Philip Brainin, MD, PhD

University Hospital, Gentofte, Copenhagen

研究点 (1)

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