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临床试验/NCT03267420
NCT03267420已完成不适用

Blood Pressure Measurement: Should Technique Define Targets?

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年10月12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
78
试验地点
2
主要终点
Casual Blood Pressure versus Omron HEM 907XL unattended

研究概览

简要总结

Hypertension is the single most important risk factor for cardiovascular disease and death, yet blood pressure itself is highly influenced by technique and device. Hence, the target blood pressure could vary materially based on BP technique and device used. In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

详细描述

Hypertension is the single most important risk factor for cardiovascular disease and death. Over the last several decades many classes of blood pressure lowering drugs have been discovered. These allow physicians to achieve optimal blood pressure and prevent adverse cardiovascular outcomes in most patients. However, the optimal blood pressure level has changed over time, and most recently has been decreased to 120 mm Hg, on the basis of clinical trials. These trials used a specific rigorous method of blood pressure measurement (patient alone in room, enforced period of rest, average of multiple readings) that is currently not the standard of practice in most clinics. Blood pressure itself is highly influenced by technique and device. In particular the length of resting time (if any), and whether it is measured with device requiring medical personnel presence in the room or not. For the same individual, the difference between blood pressure taken with and without rest could be 10 mmHg, and presence vs absence of medical personnel in the room during rest and/or BP assessment could be another 10 mmHg. Hence, the target blood pressure could vary materially based on BP technique and device used. As it is unlikely that all physicians can change their practice overnight and embrace blood pressure device allowing for standard resting time and unattended blood assessment, a comparative pragmatic study of the blood pressure technique and devices endorsed by Hypertension Canada and used in Canada is desirable to avoid either over- or under-treatment of Canadian patients with hypertension.

In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement in 90 patients. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment

排除标准

  • Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
  • inability to consent the patient

结局指标

主要结局

Casual Blood Pressure versus Omron HEM 907XL unattended

时间窗: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)

The effect of unattended 5-minute rest preceding unattended systolic blood pressure assessment will be derived from the difference between casual blood pressure (measured in mm Hg) and average resting unattended systolic blood pressure (measured in mm Hg) as measured with the Omron HEM 907 XL

次要结局

  • BpTRU versus Omron HEM 907XL with 5 minutes unattended rest(24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2))
  • Omron HEM 907XL unattended versus Omron HEM 907XL partially attended(24 hours: from Visit 1 and Visit 2 (group 3))
  • Omron HEM 907XL unattended versus ABPM device(24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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