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AbstractObjectiveThe HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management.DesignUnmasked randomised controlled trial with automated ascertainment of primary endpoint.Setting76 general practices in the United Kingdom.Participants622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet.InterventionsParticipants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines.Main outcome measuresThe primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values.ResultsAfter one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of −3.4 mm Hg (95% confidence interval −6.1 to −0.8 mm Hg) and a mean difference in diastolic blood pressure of −0.5 mm Hg (−1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction.ConclusionsThe HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded.Trial registrationISRCTN13790648.

Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20–80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure −7·0 mm Hg, 95% CI −12·0 to −2·1; p=0·0059, 24 h diastolic blood pressure −4·3 mm Hg, −7·8 to −0·8; p=0.0174, office systolic blood pressure −6·6 mm Hg, −12·4 to −0·9; p=0·0250, and office diastolic blood pressure −4·2 mm Hg, −7·7 to −0·7; p=0·0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference −6·8 mm Hg, 95% CI −12·5 to −1·1; p=0·0205), 24 h systolic blood pressure (difference −7·4 mm Hg, −12·5 to −2·3; p=0·0051), office diastolic blood pressure (difference −3·5 mm Hg, −7·0 to −0·0; p=0·0478), and 24 h diastolic blood pressure (difference −4·1 mm Hg, −7·8 to −0·4; p=0·0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. Medtronic.

In this preliminary study, we compared daytime blood pressure (BP) measurements performed by a commercially available cuffless—and continual—BP monitor (Aktiia monitor, Neuchâtel, Switzerland) and a traditional ambulatory BP monitor (ABPM; Dyasis 3, Novacor, Paris, France) from 52 patients enrolled in a 12-week cardiac rehabilitation (CR) program (Neuchâtel, Switzerland). Daytime (9am–9pm) systolic (SBP) and diastolic (DBP) BP from 7-day averaged data from Aktiia monitor were compared to 1-day averaged BP data from ABPM. No significant differences were found between the Aktiia monitor and the ABPM for SBP (μ ± σ [95% confidence interval]: 1.6 ± 10.5 [−1.5, 4.6] mmHg, P = 0.306; correlation [ R 2 ]: 0.70; ± 10/ ± 15 mmHg agreements: 60%, 84%). Marginally non-significant bias was found for DBP (−2.2 ± 8.0 [−4.5, 0.1] mmHg, P = 0.058; R 2 : 0.66; ±10/±15 mmHg agreements: 78%, 96%). These intermediate results show that daytime BP measurements using the Aktiia monitor generate data comparable to that of an ABPM monitor.

Reliable home blood pressure monitoring (HBPM) is essential to effective hypertension management; however, manual recording is subject to underreporting and inaccuracies. Mobile health technologies hold great potential as HBPM tools, but the fidelity of a smartphone app in HBPM has not been adequately assessed. The primary aim of the trial was to compare the fidelity of a smartphone app to that of a handwritten logbook in making HBPM data available to clinicians at follow-up visits. Fidelity was defined as the percentage of scheduled blood pressure (BP) recordings over a 3-week period that were properly recorded and reported to the clinic. The secondary aims were to investigate patient factors associated with HBPM fidelity and to explore the effect of time on the fidelity. A 2-arm, parallel, unblinded, randomized controlled pilot trial was conducted in a government polyclinic in Singapore. Hypertensive adults, aged 40 to 70 years, who were on antihypertensive medication and owned a smartphone were recruited and randomized by a computer-generated randomization schedule to 3 weeks of either semiautomated HBPM utilizing a Bluetooth-enabled BP monitor and a smartphone app or a fully manual process utilizing a conventional handwritten logbook. The primary outcome was home BP recording fidelity. Of the 80 patients randomized, 79 (smartphone app: 38 and logbook: 41) were included in the final analysis. Although fidelity was higher among the app users, it did not differ significantly between study arms (smartphone app: 66.7% and logbook: 52.4%; P=.21). Chinese and Indian ethnicities were associated with higher fidelity (absolute percent and 95% CI) by 35.6% (4.27 to 66.9) and 45.0% (8.69 to 81.3), respectively, in comparison with other ethnicities (P=.03); longer smartphone ownership increased fidelity on an average of 10.5% (0.83 to 20.2) per year (P=.03); the number of apps on the smartphone decreased fidelity at a rate of -0.32% (-0.58 to -0.05) per app (P=.02); years of hypertension morbidity increased fidelity at a rate of 1.56% (0.03 to 3.09) per year (P=.046); and the number of people working in the household decreased fidelity at a rate of -8.18% (-16.3 to -0.08) per additional working person (P=.048). The fidelity of the app was significantly higher in the first week (64.4%) than the second (55.1%, P=.001) and third (58.2%, P=.03) weeks of monitoring. Amid the increasing integration of health technologies into clinical practice, our study demonstrates the feasibility of smartphone app-assisted HBPM in hypertensive adults of Singapore. Our pilot study found no statistically significant difference in mean BP recording fidelity between a smartphone app and conventional handwritten logbook. However, the small sample size precludes definitive conclusions and highlights the need for a larger, adequately powered trial. ClinicalTrials.gov NCT03209024; https://clinicaltrials.gov/ct2/show/NCT03209024 (Archived by WebCite at http://www.webcitation.org/78EVWBg0T).

Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT. SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062. From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7–5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of −0·005 (95% CI −0·010 to 0·001) in the intensive treatment group and −0·001 (–0·006 to 0·005) in the standard treatment group (between-group difference −0·004, 95% CI −0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference −0·010, 95% CI −0·017 to −0·002; p=0·02), with an annual decline of −0·025 (–0·030 to −0·019) for the intensive treatment group and −0·015 (–0·021 to 0·009) for the standard treatment group. Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains. National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.

In this phase 1 study involving persons with hypertension, zilebesiran (an RNA interference therapeutic agent) was associated with decreases in angiotensin levels and systolic and diastolic blood pressure.

The nocturnal blood pressure (BP) surge in seconds (sec-surge) is defined as a brief, acute transient BP elevation over several tens of seconds, triggered by obstructive sleep apnea (OSA) and sympathetic hyperactivity. Sec-surge imposes a significant strain on the cardiovascular system, potentially triggering cardiovascular events. Quantitative evaluation of sec-surge level could be valuable in assessing cardiovascular risks. To accurately measure the detailed sec-surge, including its shape as BP rises and falls, we developed a beat-by-beat (BbB) BP monitoring device using tonometry. In addition, we developed an automatic sec-surge detection algorithm to help identify sec-surge cases in the overnight BbB BP data. The device and algorithm successfully detected sec-surges in patients with OSA. Our results demonstrated that sec-surge was associated with left ventricular hypertrophy and arterial stiffness independently of nocturnal BP level or variability. Sec-surge would be worth monitoring for assessing cardiovascular risks, in addition to nocturnal BP level.

This study evaluated the accuracy of a variety of home upper‐arm oscillometric blood pressure monitors (BPMs) from 448 participants against the FDA‐certified XYZ110 auscultatory device using simultaneous measurements. Descriptive statistics were used to summarize the key findings of the study. Device performance was evaluated referencing international standards (ISO 81060–2:2013), where a mean absolute difference of ≤5 mmHg was defined as “Accurate.” In addition, survey questionnaires completed by a subset of participants were analyzed to provide supplementary insights. A total of 448 consecutive outpatient clinical patients attending a routine clinical visit with their BPMs (male 215 and female 233) were eligible to participate in this study. The overall mean age of the participants was 62.35±12.59 years. Most of the BPMs included in this study were of the Omron brand (79.69%, n = 357), followed by Yuwell (5.8%, n = 26) and others. 76.32% of systolic blood pressure (SBP) measurements and 69.89% of diastolic blood pressure (DBP) measurements from BPMs exhibited differences of ≤5 mmHg compared to the reference calibrator. 70.89% ( n = 318) were accurate in measuring SBP, and 60.27% ( n = 270) were accurate in measuring DBP. Our study revealed that over 20% of BPMs exhibited discrepancies of more than 5 mmHg compared to a reference calibrator. Overall, the Omron U30, HEM‐7211, and U10 models demonstrated relatively higher accuracy in blood pressure measurements. Regular patient to patient validation of BPMs is crucial to ensure accurate measurements for daily use.

Objective To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure.Design Multicentre randomised controlled trial.Setting 20 primary care practices in south east Scotland.Participants 401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥135/85 mm Hg but ≤210/135 mm Hg).Intervention Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months.Main outcome measures Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation.Results 200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study.Conclusions Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective.Trial registration Current Controlled Trials ISRCTN72614272.