Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).

BACKGROUND: Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy. METHODS: The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring. DISCUSSION: Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).

Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial-First progress report.

High blood pressure (BP) and type-2 diabetes (T2DM) are forerunners of chronic kidney disease and left ventricular dysfunction. Home BP telemonitoring (HTM) and urinary peptidomic profiling (UPP) are technologies enabling risk stratification and personalized prevention. UPRIGHT-HTM (NCT04299529) is an investigator-initiated, multicenter, open-label, randomized trial with blinded endpoint evaluation designed to assess the efficacy of HTM plus UPP (experimental group) over HTM alone (control group) in guiding treatment in asymptomatic patients, aged 55-75 years, with ≥5 cardiovascular risk factors. From screening onwards, HTM data can be freely accessed by all patients and their caregivers; UPP results are communicated early during follow-up to patients and caregivers in the intervention group, but at trial closure in the control group. From May 2021 until January 2023, 235 patients were screened, of whom 53 were still progressing through the run-in period and 144 were randomized. Both groups had similar characteristics, including average age (62.0 years) and the proportions of African Blacks (81.9%), White Europeans (16.7%), women 56.2%, home (31.2%), and office (50.0%) hypertension, T2DM (36.4%), micro-albuminuria (29.4%), and ECG (9.7%) and echocardiographic (11.5%) left ventricular hypertrophy. Home and office BP were 128.8/79.2 mm Hg and 137.1/82.7 mm Hg, respectively, resulting in a prevalence of white-coat, masked and sustained hypertension of 40.3%, 11.1%, and 25.7%. HTM persisted after randomization (48 681 readings up to 15 January 2023). In conclusion, results predominantly from low-resource sub-Saharan centers proved the feasibility of this multi-ethnic trial. The COVID-19 pandemic caused delays and differential recruitment rates across centers.

Hypertension management before and under the COVID-19 pandemic: lessons and future directions.

Hypertension is a significant risk factor for cardiovascular diseases. The prevalence of hypertension and its complications is increasing yearly, yet it remains inadequately controlled worldwide. It has already been recognized that self-management, including self-measured blood pressure monitoring at home, is more important than office blood pressure monitoring. The practical application of telemedicine using digital technology was already underway. COVID-19 has promoted the popularization of these management systems in primary care, although the COVID-19 pandemic disrupted lifestyle and healthcare access. At the beginning of the pandemic, we were at the mercy of information on whether certain antihypertensive drugs, for example, might pose a risk of infection in the face of unknown infectious diseases. Over the past three years, however, much knowledge has been accumulated. It has been scientifically proven that there is no serious problem in managing hypertension in the same way as before the pandemic. That is to control blood pressure mainly through home blood pressure monitoring and continuing conventional drug therapy while modifying lifestyle. On the other hand, in the New Normal era, it is necessary to accelerate digital hypertension management and the establishment of new social networks and medical systems to prepare for the re-emergence of future pandemics while continuing to protect against infection. This review will summarize the lessons and future directions we learned from the impact of the COVID-19 pandemic on hypertension management. The COVID-19 pandemic has disrupted our daily life, restricted access to healthcare, and altered some of the conventional management of hypertension.

Digital redesign of hypertension management with practice and patient apps for blood pressure control (PIA study): A cluster-randomised controlled trial in general practices

Summary Background Long-term hypertension control prevents heart attacks and other cardiovascular diseases, yet implementation is insufficient worldwide. The redesign of hypertension management by information and communication technology (ICT) improved hypertension control, e.g., by transmission of blood pressure (BP) measurements to a central webspace. However, an easy-to-use secure patient app connected with a practice management centre is lacking. This study evaluates the effectiveness of the newly developed PIA (PC-supported case management of hypertensive patients to implement guideline-based hypertension therapy using a physician-defined and -supervised, patient-specific therapeutic algorithm) intervention with PIA-ICT and eLearning for general practices. Methods The effectiveness of the PIA intervention was evaluated in a cluster-randomised study. Practices were randomly allocated (1:1) to the intervention or the control group (usual care). Group allocation was unmasked for participants and researchers. The primary outcome was the BP control rate (BP < 140/90 mmHg) after 6–12 months. Secondary outcomes included BP changes and satisfaction with PIA-ICT. The trial is registered in the German Clinical Trials Register (DRKS00012680). Findings Starting from December 1, 2019, 64 general practices were recruited over 1 year during the COVID-19 pandemic. Overall, 848 patients were enrolled between April 15, 2020 and March 31, 2021. The study was completed Sept 30, 2021. At baseline, 636 patients (intervention: 331;control: 305) of 50 general practices met the inclusion criteria. The final dataset for analyses comprised 47 practices and 525 patients (intervention 265;control 260). In the adjusted hierarchical model, the PIA intervention increased the BP control rate significantly by 23.1% points (95% CI: 5.4–40.8%): intervention 59.8% (95% CI: 47.4–71.0%) compared to 36.7% (95% CI: 24.9–50.3%) in the control group. Systolic BP decreased by 21.1 mmHg in the intervention and 15.5 mmHg in the control group. Interpretation The PIA redesign of care processes improved BP in an outcome-relevant way. Prospectively, it may constitute an important model for hypertension care in Germany. Funding This study is funded by the German Innovation Fund (Grant number: 01NVF17002).

Changes in Blood Pressure and Measurement Frequency as Well as Heart Rate in Hypertensive Patients That Needed to Be Medical Observation at Home：a Cross-sectional Study in Wuhan

Background There were many hypertensive patients at non-high risk of developing COVID-19 that needed to be medical observation at home, but the changes in their blood pressure and measurement frequency as well as heart rate during the period are still unclear. Objective To perform an analysis of the changes in blood pressure and measurement frequency as well as heart rate in hypertensive patients that needed to be medical observation at home. Methods Through the iHealth cloud platform, data〔including age, sex, systolic blood pressure（SBP） and diastolic blood pressure（DBP）measured by the iHealth Clear （BPM1） at home, and heart rate〕were collected from December 1st, 2019 to March 27th, 2020, involving all hypertensive patients in Wuhan who had an ID number for consecutively uploading blood pressure readings, and were desensitized for removing the confidential information. The features of blood pressure during the period were analyzed. ARIMAX model was used to assess the association of age, sex, number of confirmed COVID-19 cases per day, cumulative confirmed COVID-19 deaths, time granularity and the traffic control with participants' blood pressure and hear rates. Results In total, blood pressure readings of 36 472 measurements by the participants using 1 232 iHealth Clear （BPM1） were collected during the 118-day period. Men demonstrated higher mean SBP, DBP and heart rate than women（P<0.05）. After January 23, 2020, the mean SBP of the participants decreased from （141±19）mm Hg to （138±18）mm Hg（P<0.05）. The analysis using the ARIMAX model revealed that after adjusting for month, week, age and number of confirmed COVID-19 cases per day, male participants showed a decrease in blood pressure（βSBP=-1.08×10-3, P=0.028, βDBP=-6.35×10-4, P=0.002）, and an increase in heart rate （βHR=2.02, P=0.003）and measurement frequency （βtimes=0.035, P=0.002）. But no significant changes were seen in females（P<0.05）. Conclusion In general, among hypertensive patients that needed to be medical observation at home, males were found with higher mean SBP, DBP, heart rate and blood pressure measurement frequency. And these hypertensive patients were found with decreased SBP and DBP after the implementation of traffic control. Using the Internet to store blood pressure data measured by the home blood pressure monitor for data assessment and treatment, is contribute to out-of-hospital management of blood pressure in hypertensive patients, which demonstrates the significance of Internet in combination with healthcare. © 2022 Chinese General Practice. All rights reserved.

Anxiety, home blood pressure monitoring, and cardiovascular events among older hypertension patients during the COVID-19 pandemic.

The global coronavirus disease 2019 (COVID-19) pandemic has led to a health crisis. It remains unclear how anxiety affects blood pressure (BP) and cardiovascular risk among older patients with hypertension. In this study, we extracted longitudinal data on home BP monitored via a smartphone-based application in 3724 elderly patients with hypertension from a clinical trial (60-80 years; 240 in Wuhan and 3484 in non-Wuhan areas) to examine changes in morning BP during the COVID-19 outbreak in China. Anxiety was evaluated using Generalized Anxiety Disorder-7 item scores. Changes in morning systolic BP (SBP) were analyzed for five 30-day periods during the pandemic (October 21, 2019 to March 21, 2020), including the pre-epidemic, incubation, developing, outbreak, and plateau periods. Data on cardiovascular events were prospectively collected for one year. A total of 262 individuals (7.0%) reported an increased level of anxiety, and 3462 individuals (93.0%) did not. Patients with anxiety showed higher morning SBP than patients without anxiety, and the between-group differences in SBP change were +1.2 mmHg and +1.7 mmHg during the outbreak and plateau periods (P < 0.05), respectively. The seasonal BP variation in winter among patients with anxiety was suppressed during the pandemic. Anxious patients had higher rates of uncontrolled BP. During the 1-year follow-up period, patients with anxiety had an increased risk of cardiovascular events with a hazard ratio of 2.47 (95% confidence interval, 1.10-5.58; P = 0.03). In summary, COVID-19-related anxiety was associated with a short-term increase in morning SBP among older patients and led to a greater risk of cardiovascular events. (ClinicalTrials. gov number, NCT03015311).

White Coat Uncontrolled Hypertension in Teleconsultation: A New and Frequent Entity.

INTRODUCTION: Cardiovascular risk seems not to be greater in patients with white coat uncontrolled hypertension (WUCH) than in patients with sustained blood pressure (BP) control. Therefore, its detection is important to avoid overtreatment. The COVID-19 pandemic determined a massive migration of hypertension consultations from the face-to-face modality to teleconsultations, and it is unknown whether WUCH exists in this context. AIM: We aimed to evaluate the prevalence of WUCH through home BP monitoring (HBPM) in treated hypertensive patients evaluated by teleconsultation. METHODS: We included treated hypertensive patients that owned a digital BP monitor. During teleconsultation, patients were asked to perform two BP measurements and then a 7-day HBPM, using the same device. Patients were classified as having WUCH if BP was ≥ 140 and/or 90 mmHg in teleconsultation and < 135/85 mmHg on HBPM. The prevalence of WUCH and its 95% confidence interval were estimated. One-way ANOVA, the Chi-square test or Fisher's exact test were used to compare the characteristics of these patients with the other groups. RESULTS: We included 341 patients (45.2% male, mean age 62.3 years). The prevalence of WUCH was 33.1% (95% CI 28.3-38.3%). Significant differences were found in terms of age, the number of antihypertensive drugs and the use of calcium channel blockers, all lower in the WUCH group as compared with the groups with elevated BP on HBPM. CONCLUSION: WUCH exists in teleconsultation and is very frequent. It can be easily detected though HBPM, thus avoiding overmedication, and its potential impact on side-effects and health costs.

Impact of the COVID-19 pandemic on blood pressure control: a nationwide home blood pressure monitoring study.

There are concerns that hypertension control may decrease during the COVID-19 pandemic. This study evaluated the impact of the COVID-19 pandemic on office blood pressure (OBP) and home blood pressure monitoring (HBPM) control in a large Brazilian nationwide sample. The results of an adjusted spline analysis evaluating the trajectory of OBP and HBPM control from 01/Jan/2019 to 31/Dec/2020 among independent participants who were untreated (n = 24,227) or treated (n = 27,699) with antihypertensive medications showed a modest and transient improvement in OBP control among treated individuals, which was restricted to the early months following the COVID-19 pandemic outbreak. Furthermore, slight reductions in OBP and HBPM values were detected in the early months following the COVID-19 pandemic outbreak among treated (n = 987) participants for whom blood pressure measurements before and during the pandemic were available, but not among untreated (n = 495) participants. In conclusion, we found no major adverse influence of the COVID-19 pandemic on OBP and HBPM control in a large nationwide sample.

Home Blood Pressure and Telemedicine: A Modern Approach for Managing Hypertension During and After COVID-19 Pandemic.

Hypertension is the most common cardiovascular risk factor for acute cardiovascular outcomes, including acute coronary disease, stroke, chronic kidney disease and congestive heart failure. Despite the fact that it represents the most prevalent risk factor in the general population, mostly in elderly individuals, its awareness is still relatively low, being about one third of patients living with undiagnosed hypertension and high risk of experiencing acute cardiovascular events. In addition, though recent improvement in pharmacological and non-pharmacological therapeutic options, hypertension is largely uncontrolled, with about 35-40% of treated hypertensive patients achieving the recommended therapeutic targets. Among different modern interventions proposed for improving blood pressure control in treated hypertensive patients, a systematic adoption of home BP monitoring has demonstrated to be one of the most effective. Indeed, it improves patients' awareness of the disease and adherence to prescribed medications and allows tailoring and personalizing BP lowering therapies. Home BP monitoring is particularly suitable for telemedicine and mobile-health solutions. Indeed, in specific conditions, when face-to-face interactions between patients and physicians are not allowed or even suspended, as in case of COVID-19 pandemic, telemedicine may ensure effective management of hypertension, as well as other cardiovascular and non-cardiovascular comorbidities. This review will summarize strengths and limitations of telemedicine in the clinical management of hypertension with a particular focus on the lessons learned during the COVID-19 pandemic.

Changes in Home Blood Pressure Monitored Among Elderly Patients With Hypertension During the COVID-19 Outbreak: A Longitudinal Study in China Leveraging a Smartphone-Based Application.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted clinical care worldwide. Evidence of how this health crisis affected common conditions like blood pressure (BP) control is uncertain. METHODS: We used longitudinal BP data from an ongoing randomized clinical trial to examine variations in home BP monitored via a smartphone-based application (app) in a total of 7394 elderly patients with hypertension aged 60 to 80 years stratified by their location in Wuhan (n=283) compared with other provinces of China (n=7111). Change in morning systolic BP (SBP) was analyzed for 5 30-day phases during the pandemic, including preepidemic (October 21 to November 20, 2019), incubation (November 21 to December 20, 2019), developing (December 21, 2019 to January 20, 2020), outbreak (January 21 to February 20, 2020), and plateau (February 21 to March 21, 2020). RESULTS: Compared with non-Wuhan areas of China, average morning SBP (adjusted for age, sex, body mass index) in Wuhan patients was significantly higher during the epidemic growth phases, which returned to normal at the plateau. Between-group differences in ΔSBP were +2.5, +3.0, and +2.1 mm Hg at the incubation, developing, and outbreak phases of COVID-19 (P<0.001), respectively. Sensitivity analysis showed a similar trend in trajectory pattern of SBP in both the intensive and standard BP control groups of the trial. Patients in Wuhan also had an increased regimen change in antihypertensive drugs during the outbreak compared with non-Wuhan patients. Expectedly, Wuhan patients were more likely to check their BP via the app, while doctors were less likely to monitor the app for BP control during the pandemic. CONCLUSIONS: Our data demonstrate that the COVID-19 pandemic was associated with a short-term increase in morning SBP among elderly patients with hypertension in Wuhan but not other parts of China. Further study will be needed to understand if these findings extended to other parts of the world substantially affected by the virus. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03015311.

COVID-19 and hypertension-evidence and practical management: Guidance from the HOPE Asia Network.

There are several risk factors for worse outcomes in patients with coronavirus 2019 disease (COVID-19). Patients with hypertension appear to have a poor prognosis, but there is no direct evidence that hypertension increases the risk of new infection or adverse outcomes independent of age and other risk factors. There is also concern about use of renin-angiotensin system (RAS) inhibitors due to a key role of angiotensin-converting enzyme 2 receptors in the entry of the SARS-CoV-2 virus into cells. However, there is little evidence that use of RAS inhibitors increases the risk of SARS-CoV-2 virus infection or worsens the course of COVID-19. Therefore, antihypertensive therapy with these agents should be continued. In addition to acute respiratory distress syndrome, patients with severe COVID-19 can develop myocardial injury and cytokine storm, resulting in heart failure, arteriovenous thrombosis, and kidney injury. Troponin, N-terminal pro-B-type natriuretic peptide, D-dimer, and serum creatinine are biomarkers for these complications and can be used to monitor patients with COVID-19 and for risk stratification. Other factors that need to be incorporated into patient management strategies during the pandemic include regular exercise to maintain good health status and monitoring of psychological well-being. For the ongoing management of patients with hypertension, telemedicine-based home blood pressure monitoring strategies can facilitate maintenance of good blood pressure control while social distancing is maintained. Overall, multidisciplinary management of COVID-19 based on a rapidly growing body of evidence will help ensure the best possible outcomes for patients, including those with risk factors such as hypertension.