Ambulatory Blood Pressure Monitoring Compared to Wrist Home Blood Pressure Monitoring in Assessing End-organ Damage (AW-COMPARE)
openNHLBI - National Heart Lung and Blood Institute
PROJECT SUMMARY/ABSTRACT. Guidelines recommend measuring blood pressure (BP) outside of the office setting for diagnosing hypertension and managing BP. While out-of-office BP monitoring has generally focused on awake BP, over 50% of adults with hypertension have high sleep BP. High sleep BP is associated with increased risk for cardiovascular disease (CVD) events and kidney damage independent of office and awake BP. Therefore, obtaining both awake and sleep out-of-office BP measurements is important for identifying high out-of-office BP. Ambulatory BP Monitoring (ABPM) devices, which use an upper-arm brachial cuff worn for 24 hours, are the current reference standard for out-of-office awake and sleep BP measurement. ABPM is underutilized due to patient discomfort, lack of availability to clinicians, and high cost. Home BP monitoring (HBPM) devices can also measure BP outside of the office setting. Until recently, ABPM was the only device available to measure sleep BP. Newly developed brachial and wrist-worn HBPM devices offer a promising alternative to ABPM and can potentially overcome several barriers to ABPM use. However, similar to ABPM, brachial cuff HBPM disrupts sleep and is not well tolerated. Preliminary data suggest that wrist-worn HBPM devices cause less discomfort and are less likely to disrupt sleep compared to ABPM and brachial-cuff HBPM. Thus, a wrist-worn HBPM device that measures sleep and awake BP and disrupts sleep less than ABPM could replace ABPM for out-of-office-BP measurement if sleep and awake BP on wrist-worn HBPM have strong associations with end organ damage. There are few data on the association of awake and sleep BP obtained using wrist-worn HBPM devices with end organ damage. The goal of this study is to compare the associations of sleep and awake systolic BP (SBP) measured by wrist-worn HBPM versus ABPM with left ventricular mass index (LVMI) and albuminuria, validated markers of CVD and kidney damage. We hypothesize that the associations of sleep and awake SBP with LVMI and albuminuria will be stronger for wrist-worn HBPM than for ABPM. We will enroll 742 adults with office SBP of 110-159 mm Hg, including 50% on antihypertensive medication, from Birmingham, AL and New York, NY. Participants will undergo 24-hour ABPM and 7 days of wrist-worn HBPM in random order. LVMI will be assessed by echocardiography, and albuminuria will be measured from urine samples. The proposed study will determine if a novel wrist-worn HBPM device can be used as a clinically validated alternative to ABPM for diagnosing hypertension and managing BP. This study addresses NHLBI’s mission to optimize novel diagnostic strategies to prevent CVD.
Up to $746K
health research