Background: Telemonitoring enables real-time detection and management of changes in vital signs. This study aimed to evaluate whether telemonitoring combined with telemedical care stabilizes blood pressure levels and improves the perceived safety of hypertensive patients. Methods: For six months, hypertensive patients with adverse blood pressure fluctuations participated in home telemonitoring, supported by a telemedicine center available daily. Primary care physicians defined threshold values and interventions in an action protocol. Outcomes were analyzed using blood pressure data and Patient Reported Outcome Measurements. Results: The blood pressure decreased significantly from 135/84 mmHg to 129/80 mmHg. The threshold violations dropped by 70%: systolic from 64to 19 occurrences per month, and diastolic from 81 to 24. 129 medical phone consultations were conducted, by 37 reserve medication was recommended, 6 led to physician visits, and 3 required emergency care. 55% of patients rated their safety at the highest level, and the satisfaction scores ranged from 8 to 10 out of 10. All participants (100%) would recommend the telemonitoring service. Conclusion: Telemedical care reduces adverse blood pressure fluctuations and enhances safety for hypertensive patients. Effective collaboration among healthcare providers is vital. Telemedicine complements traditional methods and supports continuous care.
In collaboration with Landesinstitut f & uuml;r Integrierte Versorgung (LIV), Versicherungsanstalt & ouml;ffentlich Bediensteter, Eisenbahnen und Bergbau (BVAEB), and AIT Austrian Institute of Technology (AIT) a Disease Management Program (DMP) for the treatment of patients with arterial hypertension was developed in Tyrol. Using the digital health solution HerzMobil (AIT telehealth platform managed by telbiomed), patients were guided by specialized nursing staffand doctors through the HerzMobil app to make lifestyle changes and, if necessary, medication adjustments. Blood pressure was transmitted to the system twice daily and monitored regularly. A total of 151 patients with elevated blood pressure readings in the outpatient 24-hour blood pressure monitoring (ABPM) participated in this project, which lasted for 3 to 6 months. At the time ofthe regular program completion-3 months after the program started-64% of participants (n=96) had controlled systolic blood pressure, and 66% of participants (n=100) had controlled diastolic blood pressure (-12 mmHg sys/-7 mmHg dia ABPM). Significant improvements were also achieved in BMI and body weight. In summary, this project demonstrated a clear improvement in blood pressure values and lifestyle. An integration of this DMP using telemedicine measures into standard care for blood pressure patients is planned for the near future. J Hyperton 2025; 29 (1): 2-5.
Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether selfmonitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, setting, and participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP selfmonitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main outcomes and measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference,-1.6 days [95% CI,-8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the selfmonitoring group vs 6 [0.5%] in the usual care group). Conclusions and relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure selfmonitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial registration: ClinicalTrials.gov Identifier: NCT03334149
Importance: Angiotensinogen is the most upstream precursor of the reninangiotensin-aldosterone system, a key pathway in blood pressure (BP) regulation. Zilebesiran, an investigational RNA interference therapeutic, targets hepatic angiotensinogen synthesis. Objective: To evaluate antihypertensive efficacy and safety of different zilebesiran dosing regimens. Design, setting, and participants: This phase-2, randomized, double -blind, dose-ranging study of zilebesiran vs placebo was performed at 78 sites across 4 countries. Screening initiation occurred in July 2021 and the last patient visit of the 6-month study occurred in June 2023. Adults with mild to moderate hypertension, defined as daytime mean ambulatory systolic BP (SBP) of 135 to 160 mm Hg following antihypertensive washout, were randomized. Interventions: Randomization to 1 of 4 subcutaneous zilebesiran regimens (150, 300, or 600 mg once every 6 months or 300 mg once every 3 months) or placebo (once every 3 months) for 6 months. Main outcomes and measures: The primary endpoint was between-group difference in least-squares mean (LSM) change from baseline to month 3 in 24-hour mean ambulatory SBP. Results: Of 394 randomized patients, 377 (302 receiving zilebesiran and 75 receiving placebo) comprised the full analysis set (93 black patients [24.7%]; 167 [44.3%] women; mean [SD] age, 57 [11] years). At 3 months, 24-hour mean ambulatory SBP changes from baseline were -7.3 mm Hg (95% CI, - 10.3 to -4.4) with zilebesiran, 150 mg, once every 6 months; -10.0 mm Hg (95% CI, -12.0 to -7.9) with zilebesiran, 300 mg, once every 3 months or every 6 months; -8.9 mm Hg (95% CI, -11.9 to - 6.0) with zilebesiran, 600 mg, once every 6 months; and 6.8 mm Hg (95% CI, 3.6-9.9) with placebo. LSM differences vs placebo in change from baseline to month 3 were -14.1 mm Hg (95% CI, -19.2 to -9.0; P < .001) with zilebesiran, 150 mg, once every 6 months; -16.7 mm Hg (95% CI, -21.2 to -12.3; P < .001) with zilebesiran, 300 mg, once every 3 months or every 6 months; and -15.7 mm Hg (95% CI, -20.8 to -10.6; P < .001) with zilebesiran, 600 mg, once every 6 months. Over 6 months, 60.9% of patients receiving zilebesiran had adverse events vs 50.7% patients receiving placebo and 3.6% had serious adverse events vs 6.7% receiving placebo. Nonserious drug-related adverse events occurred in 16.9% of zilebesiran-treated patients (principally injection site reactions and mild hyperkalemia) and 8.0% of placebo-treated patients. Conclusions and relevance: In adults with mild to moderate hypertension, treatment with zilebesiran across a range of doses at 3-month or 6-month intervals significantly reduced 24-hour mean ambulatory SBP at month 3.
Hypertensive disorders of pregnancy (HDP) affect approximately 10% of pregnant women, posing significant risks for maternal and fetal morbidity and mortality. HDP are associated with an increased risk of cardiovascular diseases, type II diabetes, and chronic kidney disease in affected women. Early diagnosis and treatment can reduce complications and long-term cardiovas cular risks. The incidence of HDP is rising due to factors like increasing maternal age and the prevalence of obesity and other cardiometabolic risk factors. HDP are classified by the timing of onset and include chronic hypertension, white coat hypertension, masked hypertension, gestational hypertension, and preeclampsia. Preeclampsia, a severe form of HDP, occurs after the 20th th week of pregnancy and is characterized by proteinuria and/or maternal organ dysfunction leading to significant maternal and fetal mortality. Screening and early detection is crucial for the management and timely treatment of preeclampsia. Understanding the physiological and pathophysio logical hemodynamic changes during pregnancy is essential for managing HDP and mitigating their long-term cardiovascular effects. J Hyperton 2024; 28 (2): 35-43.
After introductory considerations about multiple measurements, this work presents methods with which patients can check the function of their niBP monitor themselves and compare niBP monitors in a practical manner. For acceptable niBP measurement results, oscillometric wrist-type blood pressure monitors require individual calibration with regard to posture when measuring and correction factors. This paper contains a practical example of this.
Background: Aldosterone synthase controls the synthesis of aldosterone and has been a pharmacologic target for the treatment of hypertension for several decades. Selective inhibition of aldosterone synthase is essential but difficult to achieve because cortisol synthesis is catalyzed by another enzyme that shares 93% sequence similarity with aldosterone synthase. In preclinical and phase-1 studies, baxdrostat had 100:1 selectivity for enzyme inhibition, and baxdrostat at several dose levels-reduced plasma aldosterone levels but not cortisol levels. Methods: In this multicenter, placebo-controlled trial, we randomly assigned patients who had treatment-resistant hypertension, with blood pressure of 130/80 mmHg or higher, and who were receiving stable doses of at least three antihypertensive agents, including a diuretic, to receive baxdrostat (0.5 mg, 1 mg, or 2 mg) once daily for 12 weeks or placebo. The primary end point was the change in systolic blood pressure from baseline to week 12 in each baxdrostat group as compared with the placebo group. Results: A total of 248 patients completed the trial. Dose-dependent changes in systolic blood pressure of -20.3 mmHg, -17.5 mmHg, -12.1 mmHg, and -9.4 mmHg were observed in the 2-mg, 1-mg, 0.5-mg, and placebo groups, respectively. The difference in the change in systolic blood pressure between the 2-mg group and the placebo group was -11.0 mmHg (95% confidence interval [CI], -16.4 to -5.5; P<0.001), and the difference in this change between the 1-mg group and the placebo group was -8.1 mmHg (95% CI, -13.5 to -2.8; P = 0.003). No deaths occurred during the trial, no serious adverse events were attributed by the investigators to baxdrostat, and there were no instances of adrenocortical insufficiency. Baxdrostat-related increases in the potassium level to 6.0 mmol per liter or greater occurred in 2 patients, but these increases did not recur after withdrawal and reinitiation of the drug. Conclusions: Patients with treatment-resistant hypertension who received baxdrostat had dose-related reductions in blood pressure.
Background: Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist -aprocitentan in patients with resistant hypertension. Methods: PRECISION was a multicentre, blinded, randomised, parallelgroup, phase 3 study, which was done in hospitals or research centres in Europe, North America, Asia, and Australia. Patients were eligible for randomisation if their sitting systolic blood pressure was 140 mmHg or higher despite taking standardised background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: part 1 was the 4-week doubleblind, randomised, and placebo-controlled part, in which patients received aprocitentan 12 center dot 5 mg, aprocitentan 25 mg, or placebo in a 1:1:1 ratio; part 2 was a 32-week single (patient-) blind part, in which all patients received aprocitentan 25 mg; and part 3 was a 12-week double-blind, randomised, and placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes. The study is registered on ClinicalTrials.gov, NCT03541174. Findings: The PRECISION study was done from June 18, 2018, to April 25, 2022. 1965 individuals were screened and 730 were randomly assigned. Of these 730 patients, 704 (96%) completed part 1 of the study; of these, 613 (87%) completed part 2 and, of these, 577 (94%) completed part 3 of the study. The least square mean (SE) change in office systolic blood pressure at 4 weeks was -15.3 (SE 0.9) mmHg for aprocitentan 12.5 mg, -15.2 (0.9) mmHg for aprocitentan 25 mg, and -11.5 (0.9) mmHg for placebo, for a difference versus placebo of -3.8 (1.3) mmHg (97.5% CI -6.8 to -0.8, p = 0.0042) and -3.7 (1.3) mmHg (-6.7 to -0.8; p = 0.0046), respectively. The respective difference for 24-h ambulatory systolic blood pressure was -4.2 mmHg (95% CI -6.2 to -2.1) and -5.9 mmHg (-7.9 to -3.8). After 4 weeks of withdrawal, office systolic blood pressure significantly increased with placebo versus aprocitentan (5.8 mmHg, 95% CI 3.7 to 7.9, p < 0.0001). The most frequent adverse event was mild-to-moderate oedema or fluid retention, occurring in 9%, 18%, and 2% for patients receiving aprocitentan 12.5 mg, 25 mg, and placebo, during the 4-week double-blind part, respectively. This event led to discontinuation in seven patients treated with aprocitentan. During the trial, a total of 11 treatment-emergent deaths occurred, none of which were regarded by the investigators to be related to study treatment. Interpretation: In patients with resistant hypertension, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at week 4 with a sustained effect at week 40.
The ATP-regenerating enzyme CK (creatine kinase) is strongly associated with blood pressure, which lowers upon experimental CK inhibition. The enzyme is thought to affect cardiovascular hemodynamics through enhanced systemic vascular resistance, stroke volume, and cardiac contractility, but data on these parameters are lacking. We hereby report hemodynamics by CK levels in the multiethnic, cross-sectional HELIUS study (Healthy Life in an Urban Setting). Physical examination included sitting brachial blood pressure and noninvasively assessed supine systemic vascular resistance, stroke volume, cardiac output, and cardiac contractility, which we associated with resting plasma CK. Data from 14 937 men and women (mean age, 43.3; SD, 12.9) indicated that per log CK increase, blood pressure increased with 20.2 (18.9-21.4) mmHg systolic/13.0 (12.2-13.7) diastolic, an odds ratio for hypertension of 6.1 (5.1-7.2). Outcomes were similar by sex, body mass index, and ancestry, although higher blood pressures in men, with overweight/obesity, and West-African ancestry were partially explained by higher CK, with an adjusted increase in systolic/diastolic pressure of 10.5 (10.0-10.9) / 6.4 (6.0-6.7) mmHg per log CK increase. Systemic vascular resistance, stroke volume, cardiac output, and cardiac contractility (n = 7876), increased by respectively 20%, 39%, 14%, and 23% SD per log CK increase. This study indicates that the association of CK with blood pressure likely results from an increase in systemic vascular resistance and stroke volume. These data expand the knowledge on the nature of hypertension associated with CK and may inform further experiments on CK inhibition as a means to lower blood pressure.
The current Medical Device Regulation (MDR) EU 2017/745 leads to changed requirements for the manufacture of medical devices and thus also for mechanical and digital blood pressure measuring devices. An essential point is the clinical evaluation of digital blood pressure measuring devices, which contains the new standard 81060 (universal validation standard AAMI/ESH/ISO) mandatory and serves the manufacturer to prove the medical purpose of a blood pressure measuring device to the certifying notified body. A uniform availability of blood pressure measuring devices according to the MDR for the user groups of medical professionals as well as lay-persons can be expected after the transition periods have expired.
Continuous monitoring of arterial blood pressure (BP) in non-clinical (ambulatory) settings is essential for understanding numerous health conditions, including cardiovascular diseases. Besides their importance in medical diagnosis, ambulatory BP monitoring platforms can advance disease correlation with individual behaviour, daily habits and lifestyle, potentially enabling analysis of root causes, prognosis and disease prevention. Although conventional ambulatory BP devices exist, they are uncomfortable, bulky and intrusive. Here we introduce a wearable continuous BP monitoring platform that is based on electrical bioimpedance and leverages atomically thin, self-adhesive, lightweight and unobtrusive graphene electronic tattoos as human bioelectronic interfaces. The graphene electronic tattoos are used to monitor arterial BP for > 300 min, a period tenfold longer than reported in previous studies. The BP is recorded continuously and non-invasively, with an accuracy of 0.2 +/- 4.5 mmHg for diastolic pressures and 0.2 +/- 5.8 mmHg for systolic pressures, a performance equivalent to Grade A classification.
