Aims Digital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication. Methods and results This prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group (n = 199) or control (n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were −2.4 (95% confidence interval −4.5 to −0.3), −4.3 (−6.7 to −1.9), and −3.6 (−6.2 to −1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks. Conclusion The HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.

Digital therapeutics refers to the use of evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a medical condition. This approach is being increasingly investigated for the management of hypertension, a common condition that is the leading preventable cardiovascular disease risk factor worldwide. Digital interventions can help facilitate uptake of important guideline-recommended lifestyle modifications, reinforce home blood pressure monitoring, decrease therapeutic inertia, and improve medication adherence. However, current studies are only of moderate quality, and are highly heterogeneous in the interventions evaluated, comparator used, and results obtained. Therefore, additional studies are needed, focusing on the development of universally applicable and consistent digital therapeutic strategies designed with health care professional input and evaluation of these interventions in robust clinical trials with objective end points. Hopefully, the momentum for digital therapeutics triggered by the coronavirus disease 2019 pandemic can be utilized to maximize advancements in this field and drive widespread implementation.

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Asians have specific characteristics of hypertension (HTN) and its relationship with cardiovascular disease. The morning surge in blood pressure (BP) in Asians is more extended, and the association slope between higher BP and the risk for cardiovascular events is steeper in this population than in whites. Thus, 24-hour BP control including at night and in the morning is especially important for Asian patients with HTN. There are 3 components of "perfect 24-hour BP control": the 24-hour BP level, adequate dipping of nocturnal BP (dipper type), and adequate BP variability such as the morning BP surge. The morning BP-guided approach using home BP monitoring (HBPM) is the first step toward perfect 24-hour BP control. After controlling morning HTN, nocturnal HTN is the second target. We have been developing HBPM that can measure nocturnal BP. First, we developed a semiautomatic HBPM device with the function of automatic fixed-interval BP measurement during sleep. In the J-HOP (Japan Morning Surge Home Blood Pressure) study, the largest nationwide home BP cohort, we successfully measured nocturnal home BP using this device with data memory, 3 times during sleep (2, 3, and 4 am), and found that nocturnal home BP is significantly correlated with organ damage independently of office and morning BP values. The second advance was the development of trigger nocturnal BP (TNP) monitoring with an added trigger function that initiates BP measurements when oxygen desaturation falls below a variable threshold continuously monitored by pulse oximetry. TNP can detect the specific nocturnal BP surges triggered by hypoxic episodes in patients with sleep apnea syndrome. We also added the lowest heart rate-trigger function to TNP to detect the "basal nocturnal BP," which is determined by the circulating volume and structural cardiovascular system without any increase in sympathetic tonus. This double TNP is a novel concept for evaluating the pathogenic pressor mechanism of nocturnal BP. These data are now collected using an information and communication technology (ICT)-based monitoring system. The BP variability includes different time-phase variability from the shortest beat-by-beat, positional, diurnal, day-by-day, visit-to-visit, seasonal, and the longest yearly changes. The synergistic resonance of each type of BP variability would produce great dynamic BP surges, which trigger cardiovascular events. Thus, in the future, the management of HTN based on the simultaneous assessment of the resonance of all of the BP variability phenotypes using a wearable "surge" BP monitoring device with an ICT-based data analysis system will contribute to the ultimate individualized medication for cardiovascular disease.

The authors sought to determine the association between the blunted morning blood There is a significant association between morning BP surge and nocturnal BP dipping status (the greater the morning BP surge, the greater the nocturnal BP dipping, and vice versa). 2,4,9 We thus hypothesized that the increased risk of cardiovascular events in patients with a blunted morning BP surge may be partly explained by a higher prevalence of patients with reverse nocturnal BP dipping (ie, the "riser" pattern) among patients with a blunted morning BP surge. We conducted the present study to determine the association between blunted morning BP surge and nocturnal BP dipping of the riser pattern in patients with hypertension.Takeshi Fujiwara and Naoko Tomitani contributed equally to the present study.