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临床试验/NCT01303900
NCT01303900Unknown不适用

Cardiovascular Disease in Adult Haemophilia Patients

UMC Utrecht6 个研究点 分布在 2 个国家目标入组 750 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
UMC Utrecht
入组人数
750
试验地点
6
主要终点
Ischemic cardiovascular disease

研究概览

简要总结

Life expectancy of hemophilia patients has improved considerably during the past decades and is approaching that of the general population. Hemophilia patients are therefore likely to be confronted with age-related disorders in addition to their primary illness and related diseases. Little is known about the occurrence of age-related co-morbidity, especially cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk factors has been made so far.

The aim of our study is to assess the occurrence of CVD and its risk factors in a large cohort of haemophilia patients.

In this prospective multicenter cohort study in a group of 700-800 male patients with haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD history and CVD risk factors will be collected at baseline and compared with the general age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and also compared with the general population. During a follow-up period of 5 and 10 years the occurrence of CVD events will be recorded and compared with the expected occurrence based on the QRISK2 scores and with data from the general population.

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
30 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Haemophilia A or B (mild, moderate or severe)
  • Male gender
  • Age 30 years or older
  • Treated at participating haemophilia treatment center

排除标准

  • No specific exclusion criteria

结局指标

主要结局

Ischemic cardiovascular disease

时间窗: After 5 and 10 years

Cardiovascular disease risk factors

时间窗: At baseline

次要结局

  • Association between clotting factor concentrate administration and cardiovascular events(5-10 years)

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (6)

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