Home Systolic Blood Pressure Research Articles

PS-C03-9: A COMPARATIVE STUDY OF SELF-VITAL MEASUREMENTS AND TELEMEDICINE IN THE TREATMENT OF HYPERTENSION: RATIONALE AND PROTOCOL

Background: There has been a series of reports on the effectiveness of ICT-based telemedicine in the treatment of hypertension. However, sufficient evidence has not been obtained in Japan. In this study, we will clarify how push-type communication through the combination of vital data measurements including home blood pressure (HBP) obtained by IoT devices and online visits (telemedicine) affects blood pressure management. Setting: Multicenter, open-label, randomized, prospective intervention study Methods: This study (Fukushima Medical University Ethics Committee Permission no. 2021–292, now registering in jRCT) is an investigator-initiated 6-month clinical trial, which will recruit 234 patients to be randomized in Aizuwakamatsu area, Fukushima, Japan. During the whole study, HBP, body weight and physical activity data will be collected through the internet using smartphone App (OMRON CONNECT and TELEMEDEASE). This study includes 3 arms; 1: Vital data measurement without any feedback (control), 2: Vital data measurement with telemonitoring and feedback from health care professionals such as registered nurse, 3: In addition to telemonitoring and feedback, patients can engage in consulting physicians through telemedicine and receive prescription via mail when needed. Eligible patients are asymptomatic patients with hypertension who are aged 40–75 years old and can measure HBP and use smartphone App. The primary endpoint is percentage of patients achieving antihypertensive goal (mean morning and night systolic HBP < 125 mmHg). Examples of secondary endpoints include medical economics and safety of telemedicine for treatment of hypertension. Anticipated Medical Contributions: The expected outcome is that application of telemedicine on self-measurement of vital data including HBP will be superior to vital data monitoring alone in the treatment of hypertension to improve cardiovascular outcome.

S-46-6: COMPARING OFFICE, CENTRAL, HOME AND AMBULATORY BLOOD PRESSURE IN PREDICTING LEFT VENTRICULAR MASS

The blood pressure measurement method that more accurately predicts a left ventricular mass is controversial, and the evidence suggesting superiority of central over brachial measurements is contradictory. The aim of this study was to compare the relationship between the different clinic and out-of-clinic blood pressure measurements methods with left ventricular mass in patients who attended a specialised hypertension centre for a central blood pressure measurement. An analysis was performed on the correlations between left ventricular mass and central and brachial blood pressure measurements made in the clinic, and home, as well as 24-h systolic blood pressure measurements. A linear regression analysis was then performed to assess the independent relationship of each blood pressure measurement with left ventricular mass. The results on 824 treated and 123 untreated patients showed no significant differences between correlations, although home readings tended to have the best correlations. In regression adjusted models, for each 10 mmHg increase in systolic home blood pressure the left ventricular mass increased 10 g/m2 (95% CI; 3.7–27, P = .01, adjR2 0.38), and for 24-h ambulatory systolic blood pressure it increased 2.3 g/m2 (95% CI 0.76–3.9, P < .01, adjR2 0.15) in treated and untreated patients, respectively. The association of systolic blood pressure with left ventricular mass was better explained by home and 24-h ambulatory monitoring than to clinic-based measurements in treated and untreated patients, respectively. In the clinic, however, the central measurement was not superior to brachial blood pressure.

AW-AD-1: SEASONAL VARIATION IN DAY-BY-DAY BLOOD PRESSURE VARIABILITY AND ITS EFFECT ON CARDIOVASCULAR OUTCOMES

Although day-by-day home blood pressure (BP) variability has been associated with cardiovascular disease (CVD) risk, it remains unclear whether this association differs from season to season. The present study aimed to assess seasonal variation in day-by-day home BP variability (BPV) and its association with CVD risk. We analyzed the data from a nationwide, prospective observational study, the J-HOP (Japan Morning Surge-Home Blood Pressure) study, in which 14 consecutive days of home BP monitoring were conducted. The values of standard deviation (SDSBP), coefficient of variation (CVSBP), and average real variability (ARVSBP) of home systolic BP (SBP) were used as indices of day-by-day home BPV. Among 4231 participants (mean age, 64.9 ± 10.9 years, 46.7% male, 91.5% hypertensives), all three day-by-day home BPV indices were lower in summer than winter after adjusting for confounding factors. In winter, SDSBP, CVSBP, and ARVSBP were significantly associated with increased risk of CVD events (coronary artery disease, stroke, heart failure, and aortic dissection) (adjusted HR [95%CI] per 1-SD of SDSBP, 1.27 [1.03, 1.56]; CVSBP, 1.25 [1.03, 1.53]; ARVSBP, 1.44 [1.18, 1.77]). These relationships were also observed in the analysis of quartiles of BPV parameters (adjusted HR [95%CI] compared to the 1st quartile, 4th quartile of SDSBP 2.25 [1.05, 4.81]; CVSBP 2.91 [1.40, 6.03]; ARVSBP 2.71 [1.25, 5.89]). In other seasons, however, there were no significant associations between day-by-day home BPV and CVD event risk. Our findings indicate that day-by-day home BPV measured in winter is more strongly associated with future CVD incidence than that measured in other seasons.

PS-C12-6: ASSOCIATION BETWEEN DEFECATION STATUS AND BLOOD PRESSURE VARIABILITY

Background: Blood pressure variability (BPV) is an independent predictor for cardiovascular disease. Defecation status has also been linked to the risk of developing cardiovascular disease. Aim: To investigate the association between BPV and defecation status Methods: A total of 184 participants who were able to measure their home blood pressure at least 8 days per month at both baseline and 1 year later were included in the study. All participants measured home blood pressure (BP) using HEM-9700T (OMRON Healthcare). Day-to-day variability of systolic BP were evaluated by coefficient of variation (CV) of home systolic BP during one month. Data on defecation status was obtained by questionnaire survey and good defecation status was defined as having a bowel movement every day. Results: In multivariate regression analysis with the change of CV from baseline to 1 year later as the objective variable and age, gender, Good defecation status, taking medication including antihypertensive drugs, laxatives, intestinal preparations, and CV at baseline as independent variables, good defecation status is independently negatively associated with the elevated CV (β;: -0.669, P = 0.0019). Conclusion: Good defecation status is shown to be significantly associated with decreased BPV.

PS-P15-8: EFFICACY AND SAFETY OF ESAXERENONE IN HYPERTENSIVE PATIENTS WITH TYPE 2 DIABETES AND RECEIVING SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITORS (EAGLE-DH STUDY)

Objective: Hypertensive patients with type 2 diabetes mellitus (T2DM) who respond inadequately to antihypertensive therapy are at high risk for cardiorenal events and require effective treatment options. Clinical trials have shown that esaxerenone, a non-steroidal mineralocorticoid receptor blocker, has favorable antihypertensive and renoprotective effects in hypertensive patients with various characteristics including T2DM and albuminuria. However, clinical evidence is lacking regarding the concomitant use of esaxerenone and sodium-glucose cotransporter 2 (SGLT2) inhibitors in hypertensive patients with T2DM. The study aimed to evaluate the efficacy and safety of esaxerenone and SGLT2 inhibitor combination therapy in Japanese hypertensive patients with T2DM who had an inadequate response to blood pressure (BP)-lowering treatment with renin angiotensin system (RAS) inhibitor or calcium channel blocker (CCB) monotherapy or combined therapy. Design and method: EAGLE-DH (jRCTs031200273) was a multicenter, open-label, interventional study in hypertensive patients (age, ≧ 20 years) with T2DM. Inclusion criteria were previous use of antihypertensive therapy (a RAS inhibitor, CCB, or RAS inhibitor plus CCB) and oral hypoglycemic drugs (a SGLT2 inhibitor with or without one or two other oral hypoglycemic drugs) for ≧ 12 weeks; morning home systolic BP (SBP) 125 to < 160 mmHg and/or diastolic BP (DBP) 75 to < 100 mmHg; and eGFRcreat ≧ 30 mL/min/1.73m2 at baseline. Over the 24-week study period, esaxerenone dose was started at 1.25 or 2.5 mg/day, and based on the individual patient's condition, the dose could be titrated at weeks 4 and 8 to a maximum of 5 mg/day. The primary endpoints were change in morning home BP from baseline to weeks 12 and 24. Secondary endpoints included change in bedtime home BP and office BP, proportion of patients achieving target SBP/DBP (home, < 125/75 mmHg; office, < 130/80 mmHg), change in urine albumin-to-creatinine ratio (UACR), and safety variables including adverse events, eGFR, and serum potassium. Results: The study population comprised 93 patients. Baseline characteristics were mean age, 66.3 years; male, 68.8%; mean morning home SBP/DBP, 136.4/82.3 mmHg; mean UACR 145.3 mg/g creatinine; one RAS inhibitor use, 33.3%; one CCB inhibitor use, 19.4%; RAS inhibitor plus CCB, 47.3%; mean HbA1c 6.8%; mean serum potassium, 4.2 mEq/L; and mean eGFRcreat 66.8 mL/min/1.73m2. Efficacy and safety results will be presented at the conference. Conclusions: EAGLE-DH will provide the first evidence from clinical practice for the efficacy of esaxerenone plus SGLT2 inhibitor in reducing morning/bedtime home and office BP with improving albuminuria as well as for its safety profile in Japanese hypertensive patients with T2DM.

PS-P15-7: EFFECT OF ESAXERENONE ON UNCONTROLLED NOCTURNAL HYPERTENSION FIRST EVALUATED BY 2 UPPER-ARM/WRIST HOME MONITORING DEVICES (EARLY-NH STUDY)

Objective: Nocturnal hypertension is one of the phenotypes of masked hypertension, which affects 30–50% of hypertensive patients, and it cannot be adequately controlled with a single agent. The mineralocorticoid receptor (MR) is activated in an aldosterone-independent manner in diabetes, obesity, salt sensitivity, and excessive salt intake. As all of these conditions are associated with nocturnal hypertension, MR blockers which exert not only antihypertensive but also organ-protective effects are considered the optimal antihypertensive option. Recently, we have developed 2 types (upper-arm and wrist) of nocturnal home blood pressure (BP) monitoring (HBPM) devices. Using these devices, we evaluated the effects of esaxerenone on nighttime home BP and organ damage (UACR and NT-proBNP) in uncontrolled nocturnal hypertensive patients on medication using one drug, either angiotensin receptor blocker (ARB) or calcium channel blocker (CCB). Design and method: EARLY-NH study (jRCTs031200364) was a multicenter, open-label, interventional study in nocturnal hypertensive patients. Nighttime BP was automatically measured at 2, 3, and 4AM with upper-arm (OMRON HEM-9700T), and wrist (OMRON HEM-9601T) HBPM devices. The BP data were electronically collected. Inclusion criteria were: 1) aged ≧ 20 years, 2) receiving one ARB or CCB, 3) nighttime home systolic BP (SBP) ≧ 120 mmHg. Over the 12-week study period, esaxerenone was started at the initial dose of 1.25 or 2.5 mg/day, and could be titrated up to 5 mg/day at weeks 4 and 8, based on the individual patient's condition. The primary efficacy endpoint was the change from baseline in nighttime home BP [SBP and diastolic BP (DBP)] measured by the upper-arm device at week 12. Secondary endpoints included changes in nighttime home BP measured by the wrist device, and levels and control rate of office and home BPs, %change in UACR and NT-proBNP, and safety variables including adverse events, eGFR, and serum potassium. Results: The 93 patients with uncontrolled nocturnal hypertension were successfully enrolled [age: 67.6 years; man: 50.5%; ARB/CCB: 48.4/51.6%; nighttime home SBP/DBP (upper-arm: 132.4/78.4 mmHg; wrist: 130.4/73.1 mmHg); morning home SBP/DBP: 143.8/86.7 mmHg; office SBP/DBP: 147.2/84.1 mmHg; UACR: 110.4 mg/gCr; NT-proBNP: 83.7 pg/mL; serum potassium: 4.0 mEq/L; eGFR: 69.7 mL/min/1.73m2]. Results for the efficacy, safety, and exploratory analysis will be presented. Conclusions: EARLY-NH study will provide the first clinical evidence of the efficacy and safety of esaxerenone on uncontrolled nocturnal hypertension evaluated by 2 newly developed different upper-arm and wrist HBPM and on organ damage. These results will contribute to digital management of hypertension using home BP.

AW-AD-2: ASSOCIATION BETWEEN AMBULATORY BLOOD PRESSURE AND RISK OF HOME HYPERTENSION IN A NORMOTENSIVE POPULATION

Objective: Most of the hypertension management guidelines recommend out-of-office blood pressure (BP) measurement such as self-measured BP at home (home BP) and ambulatory BP monitoring for the accurate diagnosis and management of hypertension. Both out-of-office BP measurements are more useful than office BP as prognostic indicators of cardiovascular risk. However, no prospective study has assessed the longitudinal association between the two types of out-of-office BP measurements. Therefore, we investigated the association between ambulatory BP and the risk of home BP-based hypertension in a normotensive population and whether considering ambulatory BP improves the 10-year prediction model for home hypertension risk, which was developed in the previous study. Desigh and method: We followed up 410 participants (83.2% women; age, 53.6 years) without home and ambulatory hypertension in the general population of Ohasama, Japan. The Cox model was used to assess the hazard ratios for home hypertension (home BP ≧135/≧85 mmHg or initiation of antihypertensive treatment). In addition, the predictive ability for home hypertension incidence between the models adjusted for the covariates with 24-h, daytime, or nighttime SBP was examined using Harrell's C-statistics, continuous net reclassification improvement (NRI), and integrated discrimination improvement (IDI). The NRI considers changes in the estimated prediction probabilities that imply a change from one category to another between different models. IDI is defined as the difference between the discrimination slopes of a basic model and an extended model. Results: During a mean 14.2-year follow-up, 225 home hypertension incidences occurred. The hazard ratio (95% confidence interval) for home hypertension incidence per 1-standard deviation increase in 24-h systolic BP (SBP) was 1.59 (1.33–1.90) after adjustments for possible confounding factors, including baseline home SBP. Harrell's C-statistic was 0.72 (0.69–0.75) for the basic 10-year risk prediction model, which includes sex, age, BMI, current or ex-smoker status, office SBP, and baseline home SBP. By adding 24-h, daytime, or nighttime SBP to the basic model, continuous NRI and IDI significantly improved although no significant improvement in Harrell's C-statistics was observed. Conclusions: Independent of the baseline home SBP, 24-h SBP was associated with the risk of home hypertension in a normotensive population. The prediction model for home hypertension risk was improved by the addition of 24-h SBP to the basic model. It could be useful to measure ambulatory BP for the early detection of home hypertension.

PS-C23-11: CREATION OF TOMATOES WITH HIGH GABA ACCUMULATION BY GENE EDITING AND THEIR HYPOTENSIVE EFFECTS

Background and Purpose: The number of functional food products containing gamma-aminobutyric acid (GABA), which is claimed to have a hypotensive effect, will exceed 300 in Japan by 2020. GABA containing foods has surpassed the number of applications for non-digestible dextrin, which is claimed to prevent high blood sugar. Sicilian Rouge High GABA tomato (High GABA tomato) is the world's first tomato that has been approved as a gene-edited food, which uses CRISPR/Cas9 to enable a dense accumulation of GABA. In this presentation, we will report the background of the development of the GABA hyper-accumulating tomato as well as the results of an in-house monitoring survey conducted on the consumption of this tomato. Methods: Through gene editing technology, we have successfully modified the auto-inhibitor-domain of the glutamate decarboxylase gene to enhance its activity and high GABA tomatoes were produced. Thirteen in-house monitors (5 normotensive and 8 mildly hypertensive) were asked to consume the high GABA tomatoes starting in November 2021. High GABA tomatoes were consumed fresh or cooked, with a daily dosage of 5 tomatoes. The monitored participants had their home blood pressure measured twice a day, in the morning and at night, and their blood pressure was compared between the two weeks before and the two weeks after the start of tomato consumption. Results: High GABA tomatoes contain 95 mg/100 g of GABA, and eating 5 tomatoes per day provided approximately 100 mg of GABA. No clinically significant blood pressure changes were observed in the five participants with average baseline home systolic blood pressure < 135 mmHg. When the eight participants with baseline systolic blood pressure > = 135 mmHg were divided into groups, the systolic blood pressure in 3 out of 4 subjects in the upper half decreased significantly (from 155 mmHg to 150 mmHg, Δ-4.6 mmHg). On the other hand, systolic blood pressure of the lower half of the hypertensives increased significantly in 2 subjects, but the mean did not change significantly (from 137 mmHg to 139 mmHg, Δ + 1.8 mmHg). Conclusion: While further study is necessary, the results suggest that Sicilian Rouge High GABA tomato may contribute to blood pressure reduction when consumed by hypertensive individuals.

Relationship Between White-Coat Effect and Blood Pressure Variability in Essential Hypertension

Abstract Background To investigate the incidence of white-coat effect (WCE) and to analyze the relationship between WCE and blood pressure (BP) variability in essential hypertension (EH). Methods A total of 410 patients with grade 1 and 2 EH voluntarily participated in this study. BP was self-measured at home for 1 week. Based on home and office BP, the untreated subjects were divided into white-coat hypertension (WCH, n = 38) and sustained hypertension (SHT, n = 66). The treated subjects were grouped into sustained controlled hypertension (SCH, n = 131), white-coat uncontrolled hypertension (WCUH, n = 95), masked uncontrolled hypertension (MUCH, n = 16), and sustained uncontrolled hypertension (SUCH, n = 64). A subgroup analysis was performed in the treatment hypertensives whose diagnosis based on BP inside and outside the clinic. Results WCH and WCUH patients accounted for 36.5% (95% confidence interval [CI] 27.2%–45.8%) and 31.0% (95% CI 25.8%–36.2%), respectively, in this population while only accounted for 21.7% (95% CI 14.5%–28.9%) in hypertensives whose diagnosis based on office BP and out-of-office BP, which was significantly lower than that based on office BP alone (34.5%). The WCE, that was, the difference between office and home BP, in the WCH patients was significantly higher than SHT patients (P < 0.05), and stronger in the WUCH group compared with SCH and SUCH groups (P < 0.05). Home systolic BP variability exhibited decreasing trends in the WCH and WUCH patients compared with SHT and SUCH patients. Conclusions The incidences of WCH and WUCH are high in grade 1 and 2 hypertensive patients. However, the incidence of WUCH decreases in treated patients diagnosed with office and out-of-office BP. Relative to other patients, WCH and WUCH patients exhibit stronger WCE and a decreasing trend of BP variability.

Within-week variability of the home blood pressure in the NOSE study.

Objective: Few studies have investigated weekly variations in long-term home blood pressure (BP) measurement. The aim of this study was to examine the within-week variability and the difference in the day of the week on long-term home BP with or without antihypertensive medication. Design and method: This study was based on an ongoing community-based intervention study in Nose, Osaka, which was designed to assess the effect of home BP measurement on prolonging healthy life expectancy. The study included 618 participants aged 40-91 years. Participants measured their BP with an electronic oscillometric device (HEM-7281; Omron Healthcare CO., Ltd) and wrote the value on the recording book twice in morning and evening for about six months to a year. The participants were divided into 2 groups according to with or without antihypertensive medication. The within-week variability in home BP were calculated as maximum minus minimum BP (maximum-minimum difference [MMD]) by each week. The mixed model computed the last-squares means of morning and evening systolic BP (SBP) according to the category and tested the differences between all days of the week after Tukey-Kramer adjustment. Repeated-measures liner mixed model was used to analyze the factors associated with within-week variability. Results: Morning SBP was highest on Thursday (without antihypertensive medication, 128.2 mmHg; with antihypertensive medication, 134.9 mmHg) and lowest on Saturday (127.6 mmHg, 134.1 mmHg), Evening SBP was highest on Sunday (120.7 mmHg, 127.3 mmHg) regardless of antihypertensive medication. Days of the week with the highest frequency of maximum SBP was Monday in the morning (19.4%, 22.2%) and Sunday in the evening (20.7%, 25.0%) regardless of antihypertensive medication. MMD in home SBP and DBP had significant positive relationships with age, measurement in winter, mean home BP, respectively by P<0.001, regardless of antihypertensive medication. And among participants without antihypertensive medication, MMD in home morning DBP had significantly negative relationships with BMI (coefficient = -0.01, P<0.05), and MMD in home evening SBP had significantly negative relationships with present of diabetes (coefficient = -3.42, P<0.001). Conclusions: Evening SBP was highest on Sunday and days of the week with the highest frequency of maximum SBP was Monday in the morning and Sunday in the evening regardless of antihypertensive medication. These may be related with clinical evidence that cardiovascular events occur more frequently in the morning of Monday, but further analysis is needed to clarify these associations.

Association of Home and Ambulatory Blood Pressure With Cardiovascular Prognosis in Practice Hypertensive Outpatients.

Although international guidelines for hypertension management recommend home and ambulatory blood pressure (BP) monitoring, few studies have assessed which is more useful in predicting cardiovascular incidence in hypertensive outpatients. We analyzed the association of home and ambulatory BP with cardiovascular prognosis in 1336 practice outpatients with hypertension who underwent both home and ambulatory BP measurements in the J-HOP study (Japan Morning Surge-Home Blood Pressure). During the median 6.9 years of follow-up, 111 cardiovascular events occurred. Both home and ambulatory systolic BP (SBP) were associated with cardiovascular risk independent of office SBP (hazard ratio [95% CI] per 20 mm Hg of average morning and evening home SBP, 1.46 [1.11-1.93]; 24-hour ambulatory SBP, 1.41 [1.02-1.94]). Moreover, average morning and evening home SBP was also associated with cardiovascular risk even adjusted by 24-hour ambulatory SBP (hazard ratio [95%CI] per 20 mm Hg, 1.38 [1.01-1.87]), but 24-hour ambulatory SBP was not associated with cardiovascular risk adjusted by average morning and evening home SBP. Regarding this relationship, the model-fit was significantly improved by using the analysis of likelihood ratio, but that was not significant in the analysis using C statistics. Additionally, even in patients with well-controlled 24-hour ambulatory BP, uncontrolled morning home BP was associated with cardiovascular risks (hazard ratio [95% CI], 2.15 [1.02-4.50]). In patients with well-controlled average morning and evening home BP, uncontrolled ambulatory BP was not associated with cardiovascular risks. This study demonstrated the prognostic values of home and ambulatory BP in practice hypertensive outpatients. Our findings indicated the modest superiority of home BP compared to ambulatory BP to predict cardiovascular prognosis.

Abstract 12551: Self-Monitoring of Blood Pressure and Feedback Using App in Treatment of Uncontrolled Hypertension: SMART-BP Study

Introduction: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess blood pressure (BP) accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feedback for tailored recommendations and aimed to evaluate whether this feedback is superior to SMBP alone in terms of BP reduction and drug compliance improvement in patients with hypertension. Methods: Self-Monitoring of and Feed-back using APP in TReatment of UnconTrolled Blood Pressure (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. In the SMBP alone group, the patients performed home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients received additional recommendations from the application using feedback algorithm in response to the obtained BP value. The primary endpoints were mean home BP and adherence of antihypertensive medication. Follow-up visits were scheduled at 12 and 24 weeks after randomization. Results: Among total 173 patients (88 for SBMP-App and 85 for SMBP alone) with full-analysis set, 53% were men, and mean age was 59.8 years. Baseline characteristics including BP were not significantly different between the two groups. At 24 weeks, mean reduction in home systolic BP was significantly higher in SMBP-App group than SBMP alone group (-22.4±13.5 vs. -17.2±13.3, P=0.019). Also, SMBP-App group showed higher drug adherence value and proportion of ≥95% adherence than in SMBP alone group (100% [97.2%-100.0%] vs. 97.6% [94.0%-100.0%], P=0.025; 86.1% vs. 68.0%, P=0.013). Reduction in home systolic BP at 12 weeks and office systolic BP at 12 or 24 weeks were also higher in SBMP-App, similar with primary end point. Conclusions: SMBP-App is superior to SMBP alone in terms of blood pressure reduction and improved drug adherence in patients with hypertension.

Abstract 10373: Associations of Triglyceride-Glucose Index and Morning Home Blood Pressure With Microalbuminuria and Chronic Kidney Disease in the Japanese at High-Risk of Cardiovascular Disease

Introduction: Triglyceride-glucose index (TyGi) was shown to serve as a simple surrogate marker of insulin resistance, which had a significant association with impaired renal function. However, the underlying pathophysiology has not been established between insulin resistance and impaired renal function in relation to home blood pressure (BP) measurement. Hypothesis: We hypothesized that morning home BP level and TyGi were associated with impaired renal function in the Japanese at high-risk of cardiovascular disease. In addition, an interaction of morning home systolic BP (MSBP) with TyGi was assessed for impaired renal function. Methods: In the Japan Morning Surge-Home Blood Pressure Study, measurements of home BP (mean 11.2 days) were performed in the 4310 patients with one or more cardiovascular risks (64.9 years old, male 47%). TyGi was calculated as ln[fasting triglycerides (mg/dL) х fasting glucose (mg/dL)/2]. While microalbuminuria was defined as urinary albumin/creatinine ratio ≥30 mg/gCr, chronic kidney disease (CKD) was defined as estimated glomerular filtration rate &lt;60 ml/min/1.73 m 2 . Results: The mean levels of MSBP and TyGi were 138±16mmHg and 8.65±0.59, respectively. While the prevalence of microalbuminuria was 25.4%, the prevalence of CKD was 22.7%. In the logistic regression analysis adjusted for confounders including age, gender, body mass index, smoking, total cholesterol, HbA1c, use of antihypertensives, use of antidiabetics, statin use, and office SBP, MSBP (OR per 1SD, 1.39, 95%CI, 1.28-1.50, p&lt;0.001) and TyGi (OR per 1Unit, 1.31, 95%CI, 1.14-1.51, p&lt;0.001) were significantly associated with microalbuminuria. MSBP (OR per 1SD, 1.13, 95%CI, 1.04-1.23, p&lt;0.01) and TyGi (OR per 1Unit, 1.38, 95%CI, 1.19-1.61, p&lt;0.001) were also significantly associated with CKD. A significant interaction of MSBP with TyGi was not observed for microalbuminuria (p=0.17) or CKD (p=0.91). Conclusions: MSBP as well as TyGi were significant indicators of microalbuminuria and CKD. Morning BP load and insulin resistance were additively associated with impaired renal function in the high-risk Japanese population. In addition to home BP measurements, TyGi might provide additional clinically relevant information for target renal damage.

Association Between Ambulatory Blood Pressure and Risk of Home Hypertension in a Normotensive Population: The Ohasama Study.

We investigated the association between ambulatory blood pressure (BP) and the risk of home hypertension in a normotensive population and whether considering ambulatory BP improves the 10-year prediction model for home hypertension risk, which was developed in the previous Ohasama Study. In this prospective study, we followed up with 410 participants (83.2% women; age, 53.6 years) without a home and ambulatory hypertension in the general population of Ohasama, Japan. The Cox model was used to assess the hazard ratios (HRs) for home hypertension (home BP ≥ 135/≥85 mmHg or the initiation of antihypertensive treatment) and model improvement. During a mean 14.2-year follow-up, 225 home hypertension incidences occurred. The HR (95% confidence interval) for home hypertension incidence per 1-SD higher (=6.76 mmHg) 24-hour systolic BP (SBP) was 1.59 (1.33 to 1.90), after adjustments for possible confounding factors, including baseline home SBP. Harrell's C-statistics increased from 0.72 to 0.73 (P = 0.11) when 24-hour SBP was added to the basic 10-year home hypertension prediction model, which includes sex, age, body mass index, smoking status, office SBP, and baseline home SBP. Continuous net reclassification improvement (0.53, P < 0.0001) and integrated discrimination improvement (0.028, P = 0.0014) revealed improvement in the model. A total of 24-hour SBP could be an independent predictor of future home hypertension. Home BP and 24-hour BP can longitudinally influence each other in the long term.

Clinical characteristics and management of hemodialysis patients with pre-dialysis hypertension: a multicenter observational study

Background Hypertension is a leading preventable risk factor for cardiovascular disease in hemodialysis patients. Pre-dialysis systolic blood pressure (SBP) more than 160 mmHg was thought to be associated with increased risk of cardiovascular events and all-cause mortality. The present study was performed to explore the clinical characteristics and management of hemodialysis patients with pre-dialysis SBP ≥ 160 mmHg. Methods A total of 1233 patients undergoing hemodialysis from nine hemodialysis centers were enrolled. Pre-dialysis and home BP were measured and clinical data were collected. The characteristics of patients with pre-dialysis SBP ≥ 160 mmHg were explored. Clinical parameters between hypertensive and non-hypertensive patients were compared. The partial correlation analyses performed to identify the associations between BP and clinical parameters. Results There were 24.6% of the hemodialysis patients had pre-dialysis SBP ≥ 160 mmHg and the average SBP was 173.8 ± 10.9 mmHg. Only 21.4% of the patients achieved dry weight after dialysis and up to 30.2% of patients were not given combination therapies of antihypertensive drugs. Compared to patients with pre-hemodialysis SBP < 160 mmHg, patients with pre-dialysis SBP ≥ 160 mmHg had lower target-reaching rate of Kt/v and higher incidences of intradialytic hypotension and muscle spasm. Most patients (96%) with pre-dialysis SBP ≥ 160 mmHg had home SBP≥ 135 mmHg. Patients with home SBP ≥ 160 mmHg had higher left ventricular weight index and lower hemoglobin levels when compared to their counterparts with home SBP <160 mmHg. Conclusions Pre-dialysis SBP ≥ 160 mmHg is common in clinical practice and most of the patients could diagnosed to be hypertensive according to their home SBP. Patients with pre-dialysis SBP ≥ 160 mmHg are more likely to be subjected to dialysis insufficiency and intradialytic complications. Achieving dry weight and sufficient pharmacologic interventions should be strengthened to improve BP control in the hemodialysis population.

Home Blood Pressure Can Predict the Risk for Stroke/Bleeding Events in Elderly Patients With Nonvalvular Atrial Fibrillation From the ANAFIE Registry.

Blood pressure (BP) fluctuates significantly in patients with atrial fibrillation (AF); office BP measurements seem insufficient to assess AF patient risk accurately. We hypothesized that home BP could better predict the risk of stroke/systemic embolic events (SEE) and major bleeding in patients with AF than office BP. In this prespecified subcohort study of the ANAFIE (All Nippon AF in the Elderly) Registry, we evaluated the impact of home BP on the risk of stroke/SEE, major bleeding, intracranial hemorrhage, all-cause death, and net cardiovascular outcome (a composite of stroke/SEE and major bleeding). At enrollment, home BP was measured twice in the morning and evening for 7 days. In total, 4933 elderly patients (aged ≥75 years) with nonvalvular AF participated. Incidences of net cardiovascular outcome, stroke/SEE, major bleeding, and intracranial hemorrhage increased significantly with increasing home systolic BP (H-SBP). Compared with H-SBP <125 mm Hg, ≥145 mm Hg was associated with increased risk of these events. The association between H-SBP and the events was observed only in patients with ≥20 H-SBP measurements. In elderly patients with nonvalvular AF, high H-SBP (≥145 mm Hg) was a significant predictor of stroke/SEE, major bleeding, and intracranial hemorrhage risk. Strict BP control guided by the increasing number of home BP measurements may provide an accurate clinical outcome risk assessment. URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000024006.

Difference between morning and evening blood pressure at home and nocturnal hypoxia in the general practitioner-based J-HOP study.

The aim of this study was to determine the independent association of nocturnal hypoxia with morning minus evening home blood pressure (MEdif) in a cohort of outpatients with at least one cardiovascular risk. A total of 1053 participants underwent home blood pressure (BP) portable pulse oximetry measurements, and 147 (14%) had an MEdif ≥20 mmHg, where MEdif was defined as the difference between morning and evening home systolic BP. When participants were divided into quartiles according to the lowest oxygen saturation (SpO2) during the nighttime, those in the lowest quartile (range, 54-79%) were significantly more likely to have MEdif ≥20 mmHg than those in the top quartile (range, 89-97%) (adjusted odds ratio, 1.98; 95% confidence interval, 1.13-3.49). The present study revealed an association between lowest SpO2 during the nighttime and increased MEdif in a cohort of outpatients with at least one cardiovascular risk.

Day-to-Day Blood Pressure Variability and Risk of Incident Chronic Kidney Disease in a General Japanese Population.

Background Several longitudinal studies have reported that higher visit-to-visit blood pressure variability is associated with greater risk for developing chronic kidney disease. However, no population-based studies have investigated the association between day-to-day home blood pressure variability and incident chronic kidney disease. Methods and Results A total of 2342 Japanese community-dwelling residents aged ≥40 years without chronic kidney disease at baseline were followed up by annual health examinations for 10 years. Home blood pressure was measured 3 times every morning for 28 days. Day-to-day coefficients of variation of home systolic blood pressure levels were categorized into quintiles. Chronic kidney disease was defined as an estimated glomerular filtration rate<60 mL/min per 1.73 m2 or the presence of proteinuria. The hazard ratios for developing chronic kidney disease were estimated with a Cox proportional hazards model. During the follow-up period, 772 participants developed chronic kidney disease. Increased coefficients of variation of home systolic blood pressure were associated significantly with higher risk of chronic kidney disease after adjusting for confounders (P for trend <0.001): Individuals in the highest quintile of coefficients of variation had a 1.50-fold (95% CI, 1.17-1.94) greater risk of developing chronic kidney disease than those in the lowest quintile. The combination of higher coefficients of variation and higher mean value of home systolic blood pressure was associated with the multivariable-adjusted risk of developing chronic kidney disease. Conclusions These findings suggest that increased day-to-day blood pressure variability is a significant risk factor for developing chronic kidney disease in a general Japanese population.

Automatic transmission of home blood pressure data can be effective in managing hypertension: a systematic review and meta-analysis.

Home blood pressure telemonitoring (HBPT) is a useful way to manage BP. Recent advances in digital technology to automatically transmit BP data without the patient input may change the approach to long-term BP treatment and follow-up. The purpose of this review is to summarize the latest data on the HBPT with automatic data transmission. Articles in English from 1980 to 2021 were searched by electronic databases. Randomized controlled trials comparing HBPT with automatic data transmission with usual BP management and including systolic BP (SBP) and/or diastolic BP (DBP) as outcomes in hypertension patients were included in the systematic review. A meta-analysis was conducted. After removing duplicates, 474 papers were included and 23 papers were identified. The HBPT with automatic data transmission had a significant beneficial impact on BP reduction (mean difference for office SBP -6.0 mm Hg; P < 0.001). Subgroup analyses showed that the studies using smartphone applications reduced BP significantly more in the intervention group than in the control group (standardized mean difference for office and home SBP -0.25; P = 0.01) as did the studies using HBPT other than the applications. Longer observation periods showed a sustained effect, and multidisciplinary cooperation was effective. This review suggests that a care path based on HBPT with automatic data transmission can be more effective than classical management of hypertension. In particular, the studies using smartphone applications have shown beneficial effects. The results support the deployment of digital cardiology in the field of hypertension management.

ROSuvastatin and Amlodipine as free or fixed combination on theRApeutic taRgets and treatment Adherence in hypertensive, hypercholesterolemic individuals. ROSA RARA: a spontaneous, observational study conducted by italian outpatient cardiologists

Background: Hypertension and LDL hypercholesterolemia often coexist, and their effective treatment has favorable implications for cardiovascular health. We aimed at defining the impact of amlodipine and rosuvastatin as free or fixed combinations on blood pressure (BP) and LDL-cholesterol, and the satisfaction with treatment, in hypertensive individuals with LDL hypercholesterolemia. Methods: A spontaneous longitudinal observational study was conducted at Italian cardiology outpatients clinics. Eligible individuals (age ≥ 18y, informed consent, stable 5 or 10 mg amlodipine therapy in addition to a RAAS inhibitor, stable 10 or 20 mg rosuvastatin therapy) underwent home and office BP and LDL-cholesterol assessment at 12 and 24 weeks. BP and LDL-cholesterol control rates and satisfaction with the fixed combination were assessed. Results: 285 participants were enrolled (51%M; 67 ± 10y; 94 on the free combination). At 12 weeks, mean BP and LDL-cholesterol were reduced in both groups, with higher hypertension control rates in the fixed combination group; at 24 weeks they were further reduced compared with baseline, and home systolic BP was lower in the fixed than the free combination group (121.9 ± 17.6 vs 129.4 ± 8.5 mmHg; p = 0.03). Patients in the fixed combination reported higher satisfaction with this regimen than with the free combination. Conclusions: The fixed combination of calcium channel blocker and statin appears to have advantages in terms of clinical efficacy and patients’ satisfaction.