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临床试验/NCT04342468
NCT04342468已完成不适用

Relationship of Blood Pressure Variability and Cardiovascular Disease Events Among Patients With Hypertension

University of Malaya1 个研究点 分布在 1 个国家目标入组 1,736 人开始时间: 2017年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,736
试验地点
1
主要终点
The standard deviation value of blood pressure variability in treated hypertensive patients

研究概览

简要总结

Cardiovascular Disease (CV) including stroke is the leading cause of death in Malaysia Hypertension is a major contributor to this. Prevalence of hypertension in Malaysia is high (42%) in adults age 30 years or older. Besides the actual blood pressure (BP) level recently, blood pressure variability (BPV) has been recognized as an independent and strong predictor of CV events especially strokes. However, data on the BP variability and its relationship to CV events is very limited in Asia, particularly in Malaysia. Hence the investigators aim to study BPV and its relationship to CV events in treated hypertensive patients

详细描述

This will be a cross-sectional study on patients with hypertension. The 10-year retrospective data on BP, treatment, biochemical changes, kidney function and CV events will be extracted from patient records.

Eligible patients who have given written informed consent will be given a questionnaire capturing data of their socio-demographic status, weight, height and BP measured.

Those agreeable to measure their own BP at home 3 times a day for a week will be loaned a BP device to measure their own BP at home. The home BP readings will be recorded onto a provided form and returned to the investigators.

Data will be analysed to

  1. determine BPV of the clinic visit-to-visit BPV (long tem BPV)
  2. determine the day to day BPV (short term BPV)
  3. examine the BPV to CV events, kidney function, cognition
  4. determine the prevalence of white coat and masked hypertension
  5. determine the level of control of BP
  6. examine the relationship of ownership of home BP devices to control and satisfaction of treatment

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Patients on treatment for hypertension of at least 3 years
  • Patients who consent to the study

排除标准

  • those unable to give consent
  • recent (less than 6 months) of cardiovascular events (stroke, heart attack, heart failure)
  • patients on dialysis
  • patients with end stage kidney failure

结局指标

主要结局

The standard deviation value of blood pressure variability in treated hypertensive patients

时间窗: 31 Dec 2020

The various indices of day-to-day and long term Blood pressure variability will be calculated giving the actual BPV (in absolute number ) in these patients

Percentage of cardiovascular events in those with higher BPV compared to those with lower BPV

时间窗: 31 Dec 2020

BPV will be categorized as above or below the mean BPV of the entire group. The number of CV events in percentage in each group will be compared It is expected that those with higher BPV will have more CV events

次要结局

  • Percentage of Treated hypertensives with White Coat or Masked hypertension(31 Dec 2020)
  • Difference in cognition in those with higher BP variability compared to those with lower BPV(31 Dec 2020)

研究者

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

Professor Chia Yook Chin

Professor

University of Malaya

研究点 (1)

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