Home Systolic Blood Pressure Research Articles

Abstract 4138663: Peak nocturnal home blood pressure as an early and strong novel risk factor for stroke: the practitioner-based nationwide J-HOP Nocturnal BP study

Background: Clinical implications of high peak nighttime home blood pressure (BP) are currently unknown. This analysis investigated the association between peak nighttime home systolic BP (SBP) and cardiovascular events in individuals with ≥1 cardiovascular risk factor. Methods: In the Japan Morning Surge-Home Blood Pressure (J-HOP) study, nighttime home BP was automatically measured three times every night for 14 days at baseline using a nighttime home BP monitoring device (HEM-5001, Omron Healthcare). Peak nighttime home SBP was defined as average of the highest three values over the 14-night measurement period. Occurrence of cardiovascular events (stroke, coronary artery disease, heart failure, aortic dissection) was determined over a mean 7.1 years’ follow-up. Results: This analysis included 2545 individuals (mean age 63.3±10.3 years, 49% male). After adjustment for covariates (including age, sex, and average office, morning, evening, and nighttime home SBP), stroke risk was significantly higher in individuals with peak nighttime home SBP in the highest (Q5, ≥149.0 mmHg) versus lowest quintile (Q1, <119.3 mmHg) (hazard ratio [HR] 4.24, 95% confidence interval [CI] 1.07–16.77; p=0.039 overall and 8.92, 1.49–53.43; p=0.017 in the subgroup with ≥6 nighttime home SBP measurements). This increased stroke risk remained significant after controlling for day-by-day average real variability of nighttime BP. The average peak nighttime home SBP cut-off value for predicting an increased risk of incident stroke was 136 mmHg. Conclusions: We propose exaggerated peak nighttime home SBP determined from ≥6 measurements as a novel risk factor for stroke, independent of conventional office and home BP values.

Seasonal variation in home blood pressure during pregnancy and frequency of hypertensive disorders of pregnancy: a multicenter prospective study of home blood pressure measurements in pregnant women using information technology.

This multicenter prospective study investigated seasonal variation in home blood pressure (HBP) during pregnancy and its association with the frequency of hypertensive disorders of pregnancy (HDP) and developed trimester-specific upper limits of HBP according to season. Low-risk women with singleton pregnancies were recruited at six university hospitals and three maternity clinics. HBP was measured by a sphygmomanometer twice daily and recorded online using a mobile application. HBP was evaluated according to season (winter, spring, summer, and autumn) and gestational age. Of 705 women recruited, 603 were finally included. Mean diastolic HBP values were lowest in summer and highest in winter throughout pregnancy (mean difference between summer and winter, 3.5-4.6 mmHg). Mean systolic HBP values were also lowest in summer and highest in winter except during the early period of the second trimester (mean difference between summer and the season with the highest value, 2.5-3.4 mmHg). HDP was diagnosed in 32 women (5.3%). The risk of HDP was significantly higher in women who delivered in spring and autumn but not in winter compared with summer. The rounded upper limit of HBP was 120/80 mmHg in the first trimester, 120/75 mmHg in the second trimester, and 125/80 mmHg in the third trimester for summer and 125/85 mmHg, 125/80 mmHg, and 130/85 mmHg, respectively, for other seasons. Systolic and diastolic HBP were lowest in summer throughout pregnancy. Seasonal variation should be considered when interpreting HBP and the risk of HDP during pregnancy.

Effects of low-intensity isometric handgrip training on home blood pressure in hypertensive patients: a randomized controlled trial.

We examined if lower intensity isometric handgrip (IHG) training than usual load could significantly reduce home blood pressure (HBP) in treated Japanese hypertensive patients. Sixty patients (mean age, 66.9 years; 44.6% men) with high blood pressure to grade 1 hypertension level were randomly assigned to an IHG or control group. The IHG group performed IHG training for 12 weeks, followed by a 12 weeks of detraining. The control group did not any IHG training. The IHG training comprised four sets of 2-min isometric contractions at 15% of maximum voluntary contraction (MVC) or half than usual, including 1 min of rest between sets, for ≥3 days a week. At the end of the former phase, both morning and evening systolic HBP (HSBP) and evening diastolic HBP (HDBP) were significantly higher than those at baseline in the control group while neither morning nor evening HSBP remained unchanged in the IHG group. Morning HBPs increased at the end of the latter phase than those at the end of the former phase in the IHG group and remained unchanged in the control group. The change (Δ) in morning HSBP from baseline to the end of the former phase was smaller in the IHG group than that in the control group (Δ4.1 mmHg vs. Δ0.0 mmHg, p = 0.05). A similar tendency was observed after adjusting baseline HSBP and seasonal variation (p = 0.06). In conclusion, a 12-week IHG training at 15% of MVC significantly lowered morning HSBP by approximately 4.0 mmHg in treated Japanese hypertensive patients. This study showed that a 12-week IHG training at 15% of MVC lowered morning HSBP by about 4.0 mmHg in treated Japanese hypertensive patients. Continuous low-intensity IHG training may provide a stable hypotensive effect in high blood pressure to grade 1 hypertensive population.

7246 Cardiac Paraganglioma: A Rare Entity

Abstract Disclosure: L. Javed: None. L. Jonea: None. Cardiac paragangliomas are an exceptionally uncommon subset of neuroendocrine neoplasms. We present a case of a patient presenting with this condition. 70-year-old woman with pertinent past medical history of chronic veinous insufficiency complicated by recurrent abscesses of her right leg since venaseal procedure. The patient had positive IgG lambda on immunofixation that raised concerns for MGUS. Therefore, a F-18 FDG PET-CT scan was performed for further evaluation. PET-CT revealed a hypermetabolic mass in the upper inner right thigh and the right atrium (SUV 17.6) raising concern for septic thrombi. She was admitted in the hospital for initiation of antibiotic therapy. Transesophageal echocardiogram (TEE) revealed a 4.5 cm x 4.0 cm mass in the right atrioventricular (AV) groove region, extending over the root of the main pulmonary artery. Following discharge, despite completing six weeks of IV antibiotic therapy a CT scan on a subsequent clinic visit revealed the same mass as seen on TEE. CT imaging raised suspicion of neuroendocrine tumor. This led to referral to the endocrinology department. Laboratory results showed elevated normetanephrine and dopamine levels increasing likelihood of paraganglioma. Lab Results: 24 hr urine normetaneprhine :7197(N ≤ 376 mcg), 24 hr urinary dopamine :879 (N ≤400 mcg), 24 urinary metanephrine: 84 (N ≤96 mcg) & 24 hr urinary epinephrine <3 (N ≤20 mcg). Her home systolic blood pressure readings varied between 120’s & 170’s. She was initiated on Prazosin 1 mg daily in addition to the existing antihypertensive medications of nebivilol, amlodipine & furosemide. Few months later, this patient successfully underwent cardiac mass resection. Histologic findings of the resected mass were consistent with paraganglioma. Post-surgery, anti-hypertensive medications were discontinued, and blood pressure normalized to systolic readings in the 90s to 120s and diastolic readings in the 60s to 80s. Repeat biochemical tests indicated a normalization of normetanephrine & dopamine levels, validating the success of the resection. This case features an extremely rare entity cardiac paraganglioma that had an atypical clinical manifestation of being asymptomatic. Timely diagnosis and appropriate management are crucial for patient outcomes. Surgical intervention, although fundamental, bears significant risks, necessitating meticulous preoperative management to mitigate potential complications. The medical approach focuses on averting perioperative complications such as hypertensive crisis, cardiac arrhythmias and myocardial infarction. This is achieved by administering alpha and beta adrenoceptor blockers for a minimum of two weeks before the scheduled surgery. Regular follow up is also essential due to the unpredictable malignant potential of these tumors. Presentation: 6/3/2024

Home Blood Pressure Variability Risk Prediction Score for Cardiovascular Disease Using Data From the J-HOP Study.

Home blood pressure (BP) is more closely associated with cardiovascular event risk than office BP, but cardiovascular risk prediction based on home BP variability is lacking. This study developed a simple cardiovascular event prediction score, including home BP variability data, from the J-HOP study (Japan Morning Surge-Home Blood Pressure). The J-HOP study extended follow-up from December 2017 to May 2018 generated the study data set (4231 patients). Cardiovascular events included fatal/nonfatal stroke (n=94), coronary heart disease (n=124), heart failure (n=42), and aortic dissection (n=8). Cox proportional hazards models were used to predict overall cardiovascular risk. Potential covariates included age, sex, body mass index, smoking, history of diabetes, statin use, history of cardiovascular disease, total cholesterol:high-density lipoprotein cholesterol ratio, office systolic BP (SBP), mean of morning-evening average (MEave), home SBP, and average real variability of MEave home SBP. A risk score and models were constructed, and model performance was assessed. Model performance was best when average real variability of MEave SBP was included (C statistic, 0.760). The risk score assigns points for age (5-year bands), sex, cardiovascular disease history, high-density lipoprotein cholesterol, mean MEave home SBP, and average real variability of MEave home SBP. Estimated 10-year cardiovascular risk ranged from ≤0.6% (score ≤0) to >32% (score ≥26). Calibration 2 statistics values for the model (2.66) and risk score (5.29) indicated excellent goodness of fit. This simple cardiovascular disease prediction algorithm, including day-by-day home BP variability, could be used as part of a home BP-centered approach to hypertension management in clinical practice.

Personalized Food Avoidance Dietary Approach for Psoriasis and Hypertension: A Case Study and Pilot Trial

Background: The comorbidity, coheritability and common immune pathways of the inflammatory ‘chronic’ (non-communicable) diseases, suggest a shared aetiopathogenic mechanism, with phenotypic localization dependent on genetic predisposition, for example, the arteries in hypertension and the skin in psoriasis. Lifelong observation of psoriasis suggests genetically predisposed toxicity of amphiphilic fats, flavor enhancers, and nonsugar sweeteners. Aim: To conduct trials of personalized dietary intervention to abate the phenotypic expression of psoriasis and hypertension. Materials and Methods: The interventional case study of psoriasis was conducted by means of repetitive dietary challenge and avoidance testing. We then conducted an open trial of personalized nutrition on nine consenting recruits with uncomplicated essential hypertension. They were counseled on which foods to avoid or to take based on the experience gained in psoriasis. Study participants with ‘GOOD’ or ‘FAIR/POOR’ dietary compliance were compared with regard to blood pressure (BP) control, antihypertensive drug treatment requirement (ADTR), and anthropometry. Results: Data from four FAIR/POOR diet compliers and three GOOD compliers, as at 29 weeks of dietary intervention, showed mean systolic home BP values of 128.1 (±6.74) mmHg and 122.3 (±2.03) mmHg, respectively; the mean systolic automated office BP values were 139.8 (±8.80) mmHg and 108.3 (±5.55) mmHg, respectively; as at 39 weeks of dietary intervention, the mean ADTR scores were 4.2 (±2.12) and 1.03 (±0.57), respectively. Using data at baseline and from all available timepoints after dietary intervention, two-way ANOVA confirmed highly significant improvement of BP control (P < 0.0001) and reduction of ADTR score (P = 0.0008) in GOOD compliers. GOOD compliers exhibited significantly more reductions in BMI, abdominal circumference, and triceps skinfold thickness than FAIR/POOR compliers (two-way ANOVA and linear regression: P < 0.05). Conclusion: These results support the case for adverse dietary exposure avoidance to abate the phenotypic expression of chronic disease.

Protocol for a randomized controlled trial of intensive blood pressure control on cardiovascular risk reduction in patients with atrial fibrillation: Rationale and design of the CRAFT trial

BackgroundCo-morbid hypertension is strong predictor of adverse cardiovascular (CV) outcomes in patients with atrial fibrillation (AF) but the optimal target for blood pressure (BP) control in this patient population has not been clearly defined. MethodsThe Cardiovascular Risk reduction in patients with Atrial Fibrillation Trial (CRAFT) is an investigator-initiated and conducted, international, multicenter, open-label, parallel-group, blinded outcome assessed, randomized controlled trial of intensive BP control in patients with AF. The aim is to determine whether intensive BP control (target home systolic blood pressure [SBP] <120 mmHg) is superior to standard BP control (home SBP <135 mmHg) on the hierarchical composite outcome of time to CV death, number of stroke events, time to the first stroke, number of myocardial infarction (MI) events, time to the first MI, number of heart failure hospitalization (HFH) events, and time to the first HFH. A sample size of 1,675 patients is estimated to provide 80% power to detect a win-ratio of 1.50 for intensive versus standard BP control on the primary composite outcome. Study visits are conducted at 1, 2, 3, and 6 months postrandomization, and every 6 months thereafter during the study. ConclusionsThis clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF. Trial registrationThe trial is registered at ClinicalTrials.gov (NCT04347330)

Abstract P386: Predictors of Home Blood Pressure Response to Ultrasound Renal Denervation

Background: Out-of-office blood pressure measurements are recommended for hypertension (HTN) management. The RADIANCE clinical trial program showed that ultrasound renal denervation (uRDN) significantly reduces daytime ambulatory systolic blood pressure (SBP) in patients with mild-to-moderate HTN (RADIANCE-HTN SOLO, RADIANCE II) and resistant HTN (RADIANCE-HTN TRIO). Previous analyses have assessed predictors of daytime ambulatory SBP response at 2-months. This analysis assessed predictors of home SBP (HSBP) at 2-months. Method: This analysis included 250 patients who were randomized to and received uRDN and were treated per-protocol. Separate linear regression models were used to assess predictors of the change in HSBP at 2-months. Multivariable regression analysis was conducted including variables with p-value&lt;0.20. Backward selection with a stay criterion of 0.20 was used to select the predictors for the final multivariable analysis. Study was pre-defined as a covariate in the final model. Results: Patients were 69% male and 76% white; average age was 53.9 years and baseline office BP 155.5/101.5 mmHg. The only significant predictor (p&lt; 0.05) resulting from the separate linear regression models adjusting for cohort was baseline HSBP. Other predictors included in the multivariable analyses (p&lt;0.20) were sex, black race, screening medications(Y/N), orthostatic HTN, and right renal artery diameter. In the multivariable analyses, baseline HSBP was the only significant predictor of change in HSBP at 2-months (p=0.009, See Table). Conclusions: In this analysis of response to treatment with uRDN using home BPs, baseline HSBP was the only consistent significant predictor of response. Baseline BP value as a predictor of RDN response is consistent with prior analyses.

Abstract P158: Frailty and Sex are associated with Discordant Blood Pressure Measures among Very Old Adults: Results from the Atherosclerosis Risk in Communities (ARIC) Study

Background: Home blood pressure monitoring (HBPM) is increasingly used as a more accessible alternative to office blood pressure (BP). However, agreement between office and home BP among very old adults has not been characterized. Objective: To identify clinical factors related to discordance between office and home BP among very old adults. Methods: ARIC participants underwent 3 office BP measures, using an Omron HEM907XL after a 5-minute rest with a 60-second pause interval (2023). In addition, using Omron Series 10 BP7450, participants measured BP three times at home in the morning and evening after a 5-minute rest with a 60-second pause interval over an 8-day period. We subtracted mean home systolic BP (SBP) from mean office SBP to determine discordance and characterized it via Bland-Altman plots. We used adjusted linear regression to determine whether age, sex, obesity, diabetes, frailty, or hypertension medications, were associated with discordance. Results: Among 776 participants (59.3% female; mean age 84.1±3.9 [SD] years), we observed no difference between office and home SBP; however, bias increased with higher mean SBP ( Figure, Panel 1 ). Compared to home, office SBP was significantly lower among the oldest, male, and frail participants, and higher among female and robust participants ( Figure, Panel 2 ). Conclusion: In this population of very old adults, office and HBPM generated similar estimates of resting SBP. Nevertheless, resting SBP, sex, and frailty may result in discordant measures that could influence treatment decisions. Comprehensive BP monitoring, including office and HBPM, may be necessary for accurate hypertension diagnosis and management in these subgroups of very old adults.

P085 BLOOD PRESSURE AND THE CARDIOMETABOLIC PROFILE IN YOUNG ADULTS ASSISTED IN PRIMARY HEALTH CARE – LapARC MULTICENTRIC STUDY

Introduction: Hypertension, diabetes mellitus, dyslipidemia, obesity and smoking are risk factors that impact the emergence of subclinical lesions and contribute to increased cardiovascular (CV) morbidity and mortality. Objective: to evaluate the cardiometabolic profile and blood pressure levels in young adults treated in primary care in the Brazilian Unified Health System. Methods: Multicenter cross-sectional population study (arm of the LapARC study – Rio de Janeiro) approved by the Ethics Committee under registration: 5,046,133. Our center is located in the municipality of Santarém, Pará, Brazilian Amazon. Young adults (20 to 50 years old) were evaluated in relation to their cardiovascular risk profile, sociodemographic, anthropometry and laboratory tests. Office blood pressure (BP) was measured and patients underwent Home Blood Pressure Monitoring (HBPM), with a seven-day protocol. Results: 161 individuals were included (81.4% female; mean age 39.6 ± 7.9 years), 90% declared themselves black and mixed race and 27.3% had low education. More than half of the population has 3 or more CV risk factors (55.9%), with dyslipidemia being the most prevalent (60.2%), followed by hypertension (55.9%) and women with significantly more abdominal obesity (67.2% vs 30.0%, p&lt;0.001). Among hypertensives, 84.4% knew the diagnosis, of which 71 were treated, with only 31.1% reaching blood pressure control. The most frequently mentioned antihypertensives were renin-angiotensin-aldosterone system inhibitors (36.6%) and diuretics (18.6%). Men had higher office and home systolic BP levels than women (136 ± 22 vs 128 ± 23 and 127 ± 21 vs 116 ± 15, p&lt;0.05), respectively. Furthermore, the mean ankle-brachial index was 1.12 [1.07-1.20]. After HBPM, 20.9% of individuals were identified with masked hypertension, only 1.2% with white coat hypertension and 26.7% with sustained hypertension. Conclusion: although apparently healthy, this population have an adverse cardiometabolic profile, marked by low blood pressure control and the prevalence of masked hypertension, which justifies the continuation of the study.

Low-Dose Triple-Pill vs Standard-Care Protocols for Hypertension Treatment in Nigeria

With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies. To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering. Randomized, parallel-group, open-label, multicenter trial conducted in public hospital-based family medicine clinics in Nigeria. Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure-lowering drug. Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg). The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6. The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, -5.8 mm Hg [95% CI, -8.0 to -3.6]; P < .001]). At month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, -2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events. Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol. Pan African Clinical Trials Registry Identifier: PACTR202107579572114.

Randomized Trials of Renal Denervation for Uncontrolled Hypertension: An Updated Meta-Analysis.

Despite optimal medical therapy, a significant proportion of patients' blood pressure remains uncontrolled. Catheter-based renal denervation (RDN) has been proposed as a potential intervention for uncontrolled hypertension. We conducted an updated meta-analysis to assess the efficacy and safety of RDN in patients with uncontrolled hypertension, with emphasis on the differential effect of RDN in patients on and off antihypertensive medications. Online databases were searched to identify randomized clinical trials comparing efficacy and safety of RDN versus control in patients with uncontrolled hypertension. Subgroup analyses were conducted for sham-controlled trials and studies that used RDN devices that have gained or are currently seeking US Food and Drug Administration approval. Fifteen trials with 2581 patients (RDN, 1723; sham, 858) were included. In patients off antihypertensive medications undergoing RDN, a significant reduction in 24-hour ambulatory (-3.70 [95% CI, -5.41 to -2.00] mm Hg), office (-4.76 [95% CI, -7.57 to -1.94] mm Hg), and home (-3.28 [95% CI, -5.96 to -0.61] mm Hg) systolic blood pressures was noted. In patients on antihypertensive medications, a significant reduction was observed in 24-hour ambulatory (-2.23 [95% CI, -3.56 to -0.90] mm Hg), office (-6.39 [95% CI, -11.49 to -1.30]), home (-6.08 [95% CI, -11.54 to -0.61] mm Hg), daytime (-2.62 [95% CI, -4.14 to -1.11]), and nighttime (-2.70 [95% CI, -5.13 to -0.27]) systolic blood pressures, as well as 24-hour ambulatory (-1.16 [95% CI, -1.96 to -0.35]), office (-3.17 [95% CI, -5.54 to -0.80]), and daytime (-1.47 [95% CI, -2.50 to -0.27]) diastolic blood pressures. RDN significantly lowers blood pressure in patients with uncontrolled hypertension, in patients off and on antihypertensive medications, with a favorable safety profile. The efficacy of RDN was consistent in sham-controlled trials and contemporary trials using US Food and Drug Administration-approved devices.

Factors influencing the efficacy and safety of esaxerenone in hypertensive patients: a pooled analysis of five clinical studies on different comorbidities

This study aimed to identify factors associated with a strong home blood pressure (BP)-lowering effect of esaxerenone and the incidence of elevated serum potassium levels in hypertensive patients treated with esaxerenone. A pooled analysis of five multicenter, prospective, open-label single-arm studies was conducted, including 479 patients in the full analysis set (FAS) and 492 patients in the safety analysis set. Multivariate linear regression analysis of morning home systolic BP (SBP) and diastolic BP (DBP) changes from baseline to Week 12 in the FAS (primary endpoint) showed that male sex (estimated change 4.37 mmHg), office pulse rate ≥100 beats/min (25.10 mmHg), and calcium channel blocker (CCB) use as a basal antihypertensive agent (4.53 mmHg) were significantly associated with a positive estimated change (weaker BP-lowering effect) in morning home SBP. CCB use (3.70 mmHg) was associated with a positive estimated change in morning home DBP. Urine albumin‐to‐creatinine ratio 30 to <300 mg/gCr (−4.13 mmHg) was significantly associated with a negative estimated change (stronger BP-lowering effect) in morning home SBP. Based on multivariate logistic regression analysis, elevated baseline serum potassium level (≥4.5 vs < 4.5 mEq/L, odds ratio 13.502) was significantly associated with a high incidence of serum potassium level ≥5.5 mEq/L after esaxerenone treatment. In conclusion, factors associated with a strong BP-lowering effect of esaxerenone were female sex and use of renin–angiotensin system inhibitors as a basal antihypertensive drug. Patients with baseline serum potassium levels ≥4.5 mEq/L had an increased risk of developing elevated serum potassium levels (≥5.5 mEq/L) after esaxerenone treatment.

Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination ComparedWith Placebo for Initial Treatment of Hypertension.

Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension. We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety. This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154mmHg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10mg/amlodipine 1.25mg/indapamide 0.625mg), GMRx2 ½ dose (telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event. From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86mmHg and clinic BP was 138/86mmHg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were-7.3mmHg (95% CI: -4.5 to-10.2) for GMRx2 ¼ dose and-8.2mmHg (95% CI: -5.2 to-11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9mmHg. At Week 4, clinic BP control (<140/90mmHg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P< 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium<130/>150mmol/L or potassium<3.0/>6.0mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group. In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).

Antihypertensive effect of esaxerenone and correlation between brachial and wrist home monitoring devices in patients with nocturnal hypertension: A post hoc analysis of the EARLY-NH study.

Adequate management of nocturnal hypertension is crucial to reduce the risk of organ damage and cardiovascular events. The EARLY-NH study was a prospective, open-label, multicenter study conducted in Japanese patients with nocturnal hypertension who received esaxerenone treatment for 12weeks. This post hoc analysis aimed to assess (1) the relationship between changes in morning home systolic blood pressure (SBP), bedtime home SBP, and nighttime home SBP based on changes in SBP and achievement rates of target SBP levels; and (2) the correlation between nighttime home SBP measurements using brachial and wrist home BP monitoring (HBPM) devices. This analysis evaluated 82 patients who completed the 12-week treatment period. Among those who achieved target morning home SBP (<135mmHg) and target bedtime home SBP (<135mmHg), the brachial HBPM device showed achievement rates of 63.6% and 56.4%, respectively, for target nighttime home SBP (<120mmHg). The wrist device showed achievement rates of 66.7% and 63.4%, respectively, for the same targets. Significant correlations were observed between both devices for nighttime home SBP measurements at baseline (r=0.790), Week 12 (r=0.641), and change from baseline to Week 12 (r=0.533) (all, p<.001). In this patient population, approximately 60% of individuals who reached target morning or bedtime home SBP levels <135mmHg exhibited well-controlled nighttime home SBP. Although nighttime home SBP measurements obtained using both brachial and wrist HBPM devices displayed a significant correlation, the wrist device needs to be examined in more detail for clinical use.

Effects of renal denervation on blood pressure in patients with hypertension: a latest systematic review and meta-analysis of randomized sham-controlled trials.

The efficacy of renal denervation (RDN) has been controversial, but recent randomized sham-controlled trials demonstrated significant blood pressure reductions after RDN in patients with hypertension. We conducted a systematic review and updated meta-analysis to evaluate the effects of RDN on ambulatory and office blood pressures in patients with hypertension. Databases were searched up to 15 November 2023 to identify randomized, sham-controlled trials of RDN. The primary endpoint was change in 24 h ambulatory systolic blood pressure (SBP) with RDN versus sham control. The secondary endpoints were changes in 24 h ambulatory diastolic blood pressure, daytime and nighttime blood pressure (BP), office BP, and home BP. A sub-analysis determined outcomes by medication, procedure, and device. From twelve trials, 2222 patients with hypertension were randomized to undergo RDN (n = 1295) or a sham procedure (n = 927). At 2-6 months after treatment, RDN significantly reduced 24 h ambulatory SBP by 2.81 mmHg (95% confidence interval: -4.09, -1.53; p < 0.001) compared with the sham procedure. RDN also reduced daytime SBP by 3.17 mmHg (- 4.75, - 1.58; p < 0.001), nighttime SBP by 3.41 mmHg (- 4.69, - 2.13; p < 0.001), office SBP by 4.95 mmHg (- 6.37, - 3.54; p < 0.001), and home SBP by 4.64 mmHg (- 7.44, - 1.84; p = 0.001) versus the sham control group. There were no significant differences in the magnitude of BP reduction between first- and second-generation trials, between devices, or between with or without medication. These data from randomized sham-controlled trials showed that RDN significantly reduced all blood pressure metrics in medicated or unmedicated patients with hypertension, including resistant/uncontrolled hypertension.

The utility of home blood pressure load in predicting average self-measured blood pressure.

Average values for self-measured blood pressure (SMBP) more accurately reflect a patient's risk of cardiovascular disease than do office measurements. Oftentimes, however, patients provide lists of individual home blood pressure (BP) measurements, and average values cannot be computed within the time constraints of a clinic visit. In contrast, the home BP load - defined as the proportion of BP values greater than a partition value (e.g., 130 mmHg) - can be easily calculated. We examined the utility of the BP load in predicting the mean SMBP and confirming elevated SMBP. Four hundred twenty untreated adults at least 30 years of age acquired SMBP data twice in the morning and twice in the evening over 10 days. The 'true' SMBP was defined as the mean of these 40 determinations. Using all 10 days of BP data and a systolic BP threshold of 130 mmHg, the average SMBP associated with a home BP load of 0.50 was 130 mmHg, with a 95% prediction interval of 126-133 mmHg. True systolic SMBP was approximately 6 mmHg lower and higher at home BP loads of 0.25 and 0.75, respectively. There was a 90% probability that the true systolic SMBP was greater than 130 mmHg if the systolic home BP load was at least 0.60. Corresponding values for 3 days and 1 day of SMBP were at least 0.68 and at least 0.84, respectively. Our analysis demonstrates that the home BP load can be used to estimate the average BP acquired on home monitoring and confirm elevated SMBP.

Relationship between morning blood pressure variability and cerebral microbleed burden in patients with hypertension.

Cerebral microbleeds (CMBs) can be understood as a type of target organ damage caused by hypertension. We aimed to explore the association of the CMB burden with morning blood pressure (BP) variability in patients with hypertension. We divided patients with hypertension into two groups: a group with 1-10 CMBs and a group with more than 10 CMBs. The duration, grade, medication, and control of hypertension were recorded in all patients. Morning home BP measurements were performed every 3 days for a month. A total of 791 patients were recruited. Full factor model analysis showed that higher morning home diastolic BP variability (standard deviation [SD], OR=1.080, 95% CI: 1.024-1.140, P=.005; coefficient of variation [CV], OR=1.076, 95% CI: 1.028-1.128, P=.002) was associated with more than 10 CMBs. Morning home systolic and diastolic blood pressure variability (SD, CV, average real variability) in more than 10 non-lobar CMBs group was significantly higher than that in 1-10 non-lobar CMBs group (P<.05).The multivariate analysis showed higher morning home diastolic blood pressure variability (SD, OR=1.124, 95% CI: 1.031-1.224, P=.008; CV, OR=1.099, 95% CI: 1.019-1.186, P=.015; average real variability, OR=1.055, 95% CI: 0.995-1.120, P=.075) was associated with more than 10 non-lobar CMBs. There was no significant relationship between morning home systolic blood pressure variability and more than 10 non-lobar CMBs (P>.05). Higher morning home diastolic blood pressure variability was associated with more than 10 CMBs and more than 10 non-lobar CMBs.

The association of home blood pressure with all-cause mortality in hemodialysis patients: A prospective observational study.

Prior observational studies conducted in the hemodialysis population have suggested a reverse association between dialysis-unit blood pressure (BP) and mortality. The present study aimed to investigate the prognostic association of home versus dialysis-unit BP with all-cause mortality in hemodialysis patients. At baseline, 146 patients receiving maintenance hemodialysis underwent assessment of their BP with the following methods: (i) 2-week averaged routine predialysis and postdialysis BP measurements; (ii) home BP monitoring for 1 week that included duplicate morning and evening BP measurements with the use of validated devices. Over a median follow-up period of 38 months (interquartile range [IQR]: 22-54), 44 patients (31.1%) died. In Kaplan-Meier curves, predialysis and postdialysis systolic BP (SBP) was not associated with all-cause mortality, while home SBP appeared to be of prognostic significance (log rank p = 0.029). After stratifying patients into quartiles, all-cause mortality was lowest when home SBP was ranging from 128.1 to 136.8 mmHg (quartile 2). In univariate Cox regression analysis, using quartile 2 as a referent category, the risk of all-cause mortality was 3.32-fold higher in quartile 1, 1.53-fold higher in quartile 3 and 3.25-fold higher in quartile 4. The risk-association remained unchanged after adjustment for several confounding factors (adjusted hazard ratio: 4.79, 1.79, 3.63 for quartiles 1, 3, and 4 of home systolic BP, respectively). Our findings suggest that among hemodialysis patients, 1-week averaged home SBP is independently associated with all-cause mortality. In sharp contrast, SBP recorded either before or after dialysis over 2 weeks is not prognostically informative.

THE ASSOCIATION BETWEEN HYPERTENSION SUBTYPES DEFINED BY HOME BLOOD PRESSURE IN HYPERTENSIVE PATIENTS AND INCIDENCE OF HYPERTENSION MEDIATED ORGAN DAMAGE

Objective: To investigate the association between different hypertension subtypes, based on home blood pressure measurements, and new-onset hypertension mediated organ damage (HMOD). Design and method: A retrospective cohort study was conducted from January 2019 to March 2023. Patients, who aged at least 18 years and did not have HMOD, were categorized into normotension, isolated diastolic hypertension (IDH), isolated systolic hypertension (ISH), and combined systolic-diastolic hypertension (SDH) based on the average 7-consecutive-day home blood pressure. The primary outcome was a composite of the first following events of HMOD, including ischemic heart disease, heart failure, stroke, chronic kidney disease, new-onset proteinuria, and death. The secondary outcomes consisted of each HMOD and change of estimated glomerular filtration rate (eGFR). Results: The total of 2,351 patients were screened and the 1,314 patients were finally enrolled. The median follow-up period was 24.10 ± 12.54 months. Most of them were women (65.91%) and did not have diabetes mellitus (81.66%). The overall baseline eGFR was 87.75 ± 15.57 ml/min/1.73m2. The average home systolic and diastolic blood pressure were 121.76 ± 7.49/ 73.37 ± 7.10 mmHg in normotensive group, 127.84 ± 5.02/ 88.20 ± 3.48 mmHg in IDH group, 140.60 ± 6.14/ 74.79 ± 7.17 mmHg in ISH group, and 143.45 ± 9.09/ 91.74 ± 5.67 mmHg in SDH group. Multivariable Cox proportional analysis demonstrated that patients with IDH, ISH, and SDH had a similar risk of the composite primary outcome compared to normotensive individuals (adjusted HR of 1.12, 95% CI (0.52 to 2.45), p-value = 0.770 in IDH; adjusted HR of 1.25, 95% CI (0.74 to 2.10), p-value = 0.406 in ISH; adjusted HR of 0.81, 95% CI (0.34 to 1.91), p-value = 0.633 in SDH). However, ISH was significantly associated with an increased risk of slope of eGFR decline (mean change was -2.48 ml/min/1.73m2/year, 95% CI (-3.71 to -1.25), p-value &lt; 0.001). No significant associations were observed for the other secondary endpoints. Conclusions: Although hypertension subtypes defined by home blood pressure might not increase the incidence of composite HMOD, patients with ISH had significantly higher rate of annual renal function loss.