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临床试验/NCT03547856
NCT03547856招募中不适用

A Registry Study on the "Action of Controlling Ambulatory Blood Pressure to Target in Ten Thousand Patients"

Yan Li1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2018年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Composite end point of major cardiovascular and cerebrovascular events

研究概览

简要总结

24 hour ambulatory blood pressure (ABP) monitoring should be the first choice for diagnosis and treatment of hypertension according to European Societyof Hypertension (ESH) and the European Society of Cardiology (ESC) guideline on ambulatory blood pressure monitoring. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population.

Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

详细描述

Hypertension is the most common cardiovascular disease, and it is a fatal disease causing stroke, myocardial infarction and heart failure. Effective blood pressure management can greatly reduce the incidence of cardiovascular and cerebrovascular events. The control rate of hypertension in China is very severe. A national survey in 2002 showed that the control rate for hypertension was 6.1%. Another latest survey showed that among the 1.7 million Chinese aged 35 to 75, the detection rate of hypertension was 37 percent, among which the awareness rate and treatment rate and control rate were 36%, 23% and 6% respectively.

Traditionally, BP in the office or clinic has been assessed with the auscultatory technique, which has survived to this day in clinical practice. Although the technique is inherently accurate, it is dependent on observer attention to detail, which is lacking, and it provides only a momentary measurement of BP, usually under circumstances that can influence the level of BP being measured. To overcome these serious methodology problems, 24 hour ambulatory blood pressure techniques has been developed.

Ambulatory blood pressure monitoring is a major innovation in the development of hypertension diagnosis, and China has more than 20-year experience in clinical application of blood pressure monitoring. It measures blood pressure in a person's daily life and finds "masked hypertension", "white coat hypertension", "isolated nocturnal hypertension", "morning hypertension" and other special hypertension types. Compared with the office blood pressure, ambulatory blood pressure can better predict the incidence of target organ damage and cardiovascular events.

Ambulatory blood pressure monitoring not only can accurately assess blood pressure level, but also evaluate the effect of hypertensive therapy. Therefore, 24 hour ambulatory blood pressure monitoring should be the first choice for diagnosis and treatment of hypertension. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population.

Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years old
  • Clinical diagnosed hypertension with the use of antihypertensive drugs
  • A 24-hour ambulatory blood pressure monitoring was performed with validated equipment.
  • Willing to provide information about disease history and blood biochemical test data within 6 months.
  • Sign the informed consent

排除标准

  • Without antihypertensive drug use
  • Hospitalized hypertension patients
  • Non-compliant patient

结局指标

主要结局

Composite end point of major cardiovascular and cerebrovascular events

时间窗: From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years

Composite end point of major cardiovascular and cerebrovascular events

次要结局

  • the proportion of white-coat uncontrolled hypertension(From date of enrollment until study completion,an average of 3 years)
  • The control rate of clinic blood pressure(From date of enrollment until study completion,an average of 3 years)
  • the proportion of masked uncontrolled hypertension(From date of enrollment until study completion,an average of 3 years)
  • The occurrence time of cardiovascular events in different groups(From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years)
  • The control rate of 24-hour ambulatory blood pressure(From date of enrollment until study completion,an average of 3 years)

研究者

发起方
Yan Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yan Li

Professor of Cardiovascular Medicine

Shanghai Institute of Hypertension

研究点 (1)

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