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（BP）来诊断的 或技术员（参加诊所BP）。然而，这种方法提供了一个人的BP差的估计。 动态血压监测（ABPM）在诊所外每隔15至30分钟自动测量一次血压 通常设置为24小时，包括当人醒着和睡着时。虽然ABPM被认为是 作为诊断高血压的参考标准，它在美国的大多数诊所都不可用， 但是，它并不被许多患者所接受。这些问题突出表明，需要采取新的办法， 诊断高血压。加拿大的研究表明，血压测量在诊所使用自动 没有观察者在场的血压测量设备（无人值守的诊所BP）可能更接近清醒BP， ABPM高于门诊血压。然而，这些研究是不受控制的， 在就诊后测量血压;使用水银血压计测量就诊后的血压， 这不再是测量血压的推荐;通常参与者参加了非常高的诊所 BP入组。最近对收缩压干预试验（SPRINT）数据的分析表明， 在有人护理或无人护理的情况下测量时，没有发现诊所血压之间的差异。然而，与会者没有 在同一次访视中测量了参加和未参加的BP;所有参与者均服用 抗高血压药物;来自ABPM的数据不可用作参考标准。除了 清醒时血压升高，睡眠时血压升高与CVD风险增加有关。ABPM已经 唯一能测量睡眠血压的方法一种家用血压监测（HBPM）设备最近被 可以测量睡眠时的血压。与ABPM相比，这些HBPM设备的佩戴时间更短， 一段时间（仅在睡眠期间），血压测量较少，因此可能比ABPM耐受性更好。 本研究的目的是比较新的非ABPM方法与ABPM方法在测量血压过程中的差异。 清醒和睡眠期以及诊断高血压。对于目标1，我们将测试是否无人值守 门诊血压比门诊血压提供了更准确的ABPM清醒血压估计值。目标2： 确定用于测量睡眠BP的新HBPM设备的准确性。我们还将评估 HBPM器械的耐受性优于ABPM。对于目标3，我们将比较无人值守诊所 BP和就诊时的诊室BP与ABPM的清醒BP和HBPM的睡眠BP与ABPM的左侧 心室质量指数和蛋白尿。我们将招募630名未服用抗高血压药物的成人， 在纽约州纽约和阿拉巴马州伯明翰，收缩压为110 - 159 mm Hg，舒张压为70 - 99 mm Hg。 受试者将接受随机顺序的无人值守和有人值守诊所BP，以及ABPM和HBPM， 随机排列这项严格设计的研究将提供重要数据，说明这些新方法是否 可以取代进行ABPM的需要，以评估清醒和睡眠BP并诊断高血压。

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.