Evaluating novel approaches for estimating awake and sleep blood pressure

在美国，高血压是由医疗保健提供者在诊所测量血压来诊断的 或技术员(到BP诊所就诊)。然而，这种方法对一个人的血压估计很差。 动态血压监测(ABPM)在诊所外每15到30分钟自动测量一次血压 通常为24小时，包括当一个人醒着和睡着的时候。尽管ABPM被认为是 诊断高血压的参考标准，在美国大多数诊所都没有，当 可用，但许多患者不能耐受。这些问题突出表明，需要采取新的方法来 诊断高血压。加拿大的研究表明，在诊所使用自动血压测量仪测量血压 没有观察者在场的示波测量设备(无人值守的临床BP)可能更接近于唤醒BP ABPM较BP门诊就诊时间短。然而，这些研究是无对照的，无人看管的临床BP是 就诊后测量血压；就诊血压使用汞血压计进行测量， 这不再是测量血压的推荐方法；而且经常有非常高就诊率的参与者 英国石油公司入选。最近对收缩压干预试验(SPRINT)的数据进行了分析 在有人照看和无人看管的情况下测量血压时，没有发现诊所血压的差异。然而，参与者并没有 在同一次访问中同时测量了有无人值守的BP；所有参与者都在服用 抗高血压药物；ABPM的数据没有作为参考标准。除了……之外 清醒时血压升高、睡眠时血压升高与心血管疾病风险增加有关。ABPM一直是 唯一可以测量睡眠血压的方法。一种家用血压监测(HBPM)设备最近被 开发了一种可以在睡眠时测量血压的仪器。与ABPM相比，这些HBPM设备的佩戴时间更短 血压测量值较少的一段时间(仅在睡眠期间)，因此可能比动态血压监测更耐受。 这项研究的目的是比较新的非ABPM方法和ABPM方法在测量血压方面的差异 清醒和睡眠期和高血压的诊断。对于目标1，我们将测试无人值守 与门诊血压相比，门诊血压能更准确地估计动态血压监测中的清醒血压。对于目标2，我们将 确定一种新的HBPM设备测量睡眠血压的准确性。我们还将评估是否 HBPM器件比ABPM具有更好的耐受性。对于目标3，我们将比较无人值守诊所的关联 血压和就诊血压与ABPM的清醒血压和HBPM的睡眠BP与左侧的ABPM 心室重量指数和蛋白尿。我们将招募630名成年人，不服用降压药， 纽约、纽约和亚利桑那州伯明翰的收缩压在110到159毫米汞柱之间，舒张压在70到99毫米汞柱之间。 参与者将按随机顺序接受无人看管和有人看守的诊所BP，ABPM和HBPM也 按随机顺序排列。这项精心设计的研究将提供重要数据，说明这些新方法 可以取代进行动态血压监测以评估清醒和睡眠血压以及诊断高血压的需要。

In the US, hypertension is diagnosed by measuring blood pressure (BP) in the clinic by a healthcare provider or technician (attended clinic BP). However, this approach provides a poor estimate of a person's BP. Ambulatory BP monitoring (ABPM) measures BP automatically every 15 to 30 minutes outside of the clinic setting typically for 24 hours including while a person is awake and asleep. Although ABPM is considered to be the reference standard for diagnosing hypertension, it is not available in most clinics in the US and, when available, it is not tolerated by many patients. These issues highlight the need for new approaches for diagnosing hypertension. Canadian studies suggest that BP measured in the clinic using an automatic oscillometric device without an observer being present (unattended clinic BP) may be closer to awake BP on ABPM than attended clinic BP. However, these studies were uncontrolled with unattended clinic BP being measured after attended clinic BP; attended clinic BP was performed using a mercury sphygmomanometer, which is no longer the recommended for measuring BP; and often participants with very high attended clinic BP were enrolled. A recent analysis of data from the Systolic Blood Pressure Intervention Trial (SPRINT) did not find a difference between clinic BP when measured attended or unattended. However, participants did not have both attended and unattended BP measured at the same visit; all participants were taking antihypertensive medication; and data from ABPM were not available as a reference standard. In addition to elevated awake BP, elevated BP during sleep is associated with an increased risk of CVD. ABPM has been the only method that could measure sleep BP. A home BP monitoring (HBPM) device has recently been developed that can measure BP during sleep. In contrast to ABPM, these HBPM devices are worn for a shorter period of time (only during sleep) with fewer BP measurements, and thus may be better tolerated than ABPM. The goal of this study is to compare novel non-ABPM approaches to ABPM for measuring BP during the awake and sleep periods and diagnosing hypertension. For Aim 1, we will test whether unattended clinic BP provides a more accurate estimate of awake BP on ABPM than attended clinic BP. For Aim 2, we will determine the accuracy of a new HBPM device for measuring sleep BP. We will also evaluate whether the HBPM device is better tolerated than ABPM. For Aim 3, we will compare the associations of unattended clinic BP and attended clinic BP versus awake BP on ABPM and sleep BP on HBPM versus ABPM with left ventricular mass index and albuminuria. We will enroll 630 adults, not taking antihypertensive medication, with systolic BP of 110 to 159 mm Hg and diastolic BP of 70 to 99 mm Hg in New York, NY and Birmingham, AL. Participants will undergo both unattended and attended clinic BP, in random order, and ABPM and HBPM, also in random order. This rigorously designed study will provide important data on whether these new approaches can replace the need for conducting ABPM to assess awake and sleep BP and diagnose hypertension.