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临床试验/NCT01196273
NCT01196273已完成不适用

HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

University Hospital, Essen5 个研究点 分布在 1 个国家目标入组 1,424 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,424
试验地点
5
主要终点
Cardiovascular Diseases in HIV-infected Patients

研究概览

简要总结

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart.

Heart conditions that have been described with HIV include

  • Pericarditis,
  • Pleural effusion
  • Pulmonary hypertension (Venedic classification typ II)
  • Dilated cardiomyopathy
  • Heart failure
  • Myocarditis
  • Bacterial endocarditis
  • Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research.

The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases.

Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects.

Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients.

The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.

详细描述

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

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

  • Age > 18 years
  • Known HIV-infection
  • Written informed consent

排除标准

  • Acute cardiovascular disease
  • Unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy

结局指标

主要结局

Cardiovascular Diseases in HIV-infected Patients

时间窗: Baseline up to 5 years follow-up

The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease - in HIV-infected patients.

次要结局

  • Cardiovascular Disorders in HIV-infected Patients HIV-HEART(Baseline up to 5 years follow-up)

研究者

发起方
University Hospital, Essen
申办方类型
Other

研究点 (5)

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