24-hour Ambulatory Systolic Blood Pressure Research Articles

Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results from the TARGET BP I Randomized Clinical Trial.

Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN has not been formally studied in this indication. TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN. Patients with office systolic blood pressure (SBP) ≥150 and ≤180 mmHg, office diastolic BP ≥90 mmHg and mean 24-hour ambulatory SBP ≥135 and ≤170 mmHg, despite prescription of 2-5 antihypertensive medications were enrolled. The primary endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 3 months post procedure. Secondary endpoints include mean between-group differences in office and ambulatory BP at additional time points. Among 301 patients randomized 1:1 to RDN or sham control, RDN was associated with a significant reduction in 24-hour ambulatory SBP at 3 months (mean ± standard deviation -10.0 ± 14.2 mmHg versus -6.8 ± 12.1 mmHg, treatment difference -3.2 mmHg, 95% confidence interval [CI] -6.3, 0.0 mmHg; P=0.0487). Subgroup analysis of the primary endpoint revealed no significant interaction across predefined subgroups. At 3 months, the mean change in office SBP was -12.7 ± 18.3 mmHg and -9.7 ± 17.3 mmHg (difference, -3.0, 95% CI -7.0, 1.0; P=0.173), for RDN and sham, respectively. No significant differences in ambulatory or office diastolic BP were observed. Adverse safety events through 6 months were uncommon with 1 instance of accessory renal artery dissection in the RDN group (0.7%). No significant between-group differences in medication changes or patient adherence were identified. Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory systolic BP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed.

Design and rationale of the Comprehensive intelligent Hypertension managEment SyStem (CHESS) evaluation study: a cluster randomized controlled trial for hypertension management in primary care

BackgroundHypertension management in China is suboptimal with high prevalence and low control rate due to various barriers, including lack of self-management awareness of patients and inadequate capacity of physicians. Digital therapeutic interventions including mobile health and computational device algorithms such as clinical decision support systems (CDSS) are scalable with the potential to improve blood pressure (BP) management and strengthen the healthcare system in resource-constrained areas, yet their effectiveness remains to be tested. The aim of this report is to describe the protocol of the Comprehensive intelligent Hypertension managEment SyStem (CHESS) evaluation study assessing the effect of a multi-faceted hypertension management system for supporting patients and physicians on BP lowering in primary care settings. Materials and MethodsThe CHESS evaluation study is a parallel-group, cluster-randomized controlled trial conducted in primary care settings in China. 41 primary care sites from 3 counties of China are randomly assigned to either the usual care or the intervention group with the implementation of the CHESS system, more than 1600 patients aged 35-80 years with uncontrolled hypertension and access to a smartphone by themselves or relatives are recruited into the study and followed up for 12 months. In the intervention group, participants receive patient-tailored reminders and alerts via messages or intelligent voice calls triggered by uploaded home blood pressure monitoring data and participants’ characteristics, while physicians receive guideline-based prescription instructions according to updated individual data from each visit, and administrators receive auto-renewed feedback of hypertension management performance from the data analysis platform. The multiple components of the CHESS system can work synergistically and have undergone rigorous development and pilot evaluation using a theory-informed approach. The primary outcome is the mean change in 24-hour ambulatory systolic BP from baseline to 12-month. DiscussionThe CHESS trial will provide evidence and novel insight into the effectiveness and feasibility of an implementation strategy using a comprehensive digital BP management system for reducing hypertension burden in primary care settings. Trial registrationhttps://www.clinicaltrials.gov, NCT05605418

Prognostic impact of hypertension grading

BackgroundMost Hypertension Guidelines grade hypertension according to various cut-off values. We sought to investigate the prognostic impact of Grades 1 (140–159 and/or 90–99 mmHg), 2 (160–179 and/or 100–109 mmHg) and 3 (≥180 and/or ≥110 mmHg). MethodsWe followed for an average of 10 years a cohort of 3,150 initially untreated hypertensive patients (mean age 50 years, 44 % women) with no previous cardiovascular disease at entry. All patients underwent diagnostic tests including 24-hour ambulatory blood pressure (BP) monitoring. ResultsAt entry, average clinic BP was 156/97 mmHg and average 24-hour BP was 137/87 mmHg. During follow-up, 314 patients experienced a first major cardiovascular event (composite of non-fatal myocardial infarction or stroke, cardiovascular death, or hospitalization for heart failure). Event rate was not formally dissimilar between Grade 1 and Grade 2 (0.73 vs 0.95 per 100 patient-years, respectively; p = 0.06). It was higher in Grade 3 (1.93 per 100 patient-years; p < 0.01 vs Grade 1 and Grade 2). After adjustment for a robust set of covariables, the hazard ratio was not dissimilar between Grade 1 and Grade 2 (p = 0.27), and higher in Grade 3 than in Grade 1 (p < 0.01), but the excess risk in Grade 3 was no longer significant (hazard ratio: 1.25, 95 % CI 0.87–1.78; p = 0.22) after adjustment for 24-hour ambulatory systolic BP. ConclusionsWe were unable to find a significant difference in the relative hazard of cardiovascular events tied to hypertension Grades 1 and 2. Conversely, Grade 3 (clinic BP ≥180/110 mmHg) portends a higher cardiovascular risk, which is associated with higher levels of 24-hour ambulatory BP.

RNA Interference With Zilebesiran for Mild to Moderate Hypertension

Angiotensinogen is the most upstream precursor of the renin-angiotensin-aldosterone system, a key pathway in blood pressure (BP) regulation. Zilebesiran, an investigational RNA interference therapeutic, targets hepatic angiotensinogen synthesis. To evaluate antihypertensive efficacy and safety of different zilebesiran dosing regimens. This phase 2, randomized, double-blind, dose-ranging study of zilebesiran vs placebo was performed at 78 sites across 4 countries. Screening initiation occurred in July 2021 and the last patient visit of the 6-month study occurred in June 2023. Adults with mild to moderate hypertension, defined as daytime mean ambulatory systolic BP (SBP) of 135 to 160 mm Hg following antihypertensive washout, were randomized. Randomization to 1 of 4 subcutaneous zilebesiran regimens (150, 300, or 600 mg once every 6 months or 300 mg once every 3 months) or placebo (once every 3 months) for 6 months. The primary end point was between-group difference in least-squares mean (LSM) change from baseline to month 3 in 24-hour mean ambulatory SBP. Of 394 randomized patients, 377 (302 receiving zilebesiran and 75 receiving placebo) comprised the full analysis set (93 Black patients [24.7%]; 167 [44.3%] women; mean [SD] age, 57 [11] years). At 3 months, 24-hour mean ambulatory SBP changes from baseline were -7.3 mm Hg (95% CI, -10.3 to -4.4) with zilebesiran, 150 mg, once every 6 months; -10.0 mm Hg (95% CI, -12.0 to -7.9) with zilebesiran, 300 mg, once every 3 months or every 6 months; -8.9 mm Hg (95% CI, -11.9 to -6.0) with zilebesiran, 600 mg, once every 6 months; and 6.8 mm Hg (95% CI, 3.6-9.9) with placebo. LSM differences vs placebo in change from baseline to month 3 were -14.1 mm Hg (95% CI, -19.2 to -9.0; P < .001) with zilebesiran, 150 mg, once every 6 months; -16.7 mm Hg (95% CI, -21.2 to -12.3; P < .001) with zilebesiran, 300 mg, once every 3 months or every 6 months; and -15.7 mm Hg (95% CI, -20.8 to -10.6; P < .001) with zilebesiran, 600 mg, once every 6 months. Over 6 months, 60.9% of patients receiving zilebesiran had adverse events vs 50.7% patients receiving placebo and 3.6% had serious adverse events vs 6.7% receiving placebo. Nonserious drug-related adverse events occurred in 16.9% of zilebesiran-treated patients (principally injection site reactions and mild hyperkalemia) and 8.0% of placebo-treated patients. In adults with mild to moderate hypertension, treatment with zilebesiran across a range of doses at 3-month or 6-month intervals significantly reduced 24-hour mean ambulatory SBP at month 3. ClinicalTrials.gov Identifier: NCT04936035.

Effect of Tai Chi vs Aerobic Exercise on Blood Pressure in Patients With Prehypertension

Prehypertension increases the risk of developing hypertension and other cardiovascular diseases. Early and effective intervention for patients with prehypertension is highly important. To assess the efficacy of Tai Chi vs aerobic exercise in patients with prehypertension. This prospective, single-blinded randomized clinical trial was conducted between July 25, 2019, and January 24, 2022, at 2 tertiary public hospitals in China. Participants included 342 adults aged 18 to 65 years with prehypertension, defined as systolic blood pressure (SBP) of 120 to 139 mm Hg and/or diastolic BP (DBP) of 80 to 89 mm Hg. Participants were randomized in a 1:1 ratio to a Tai Chi group (n = 173) or an aerobic exercise group (n = 169). Both groups performed four 60-minute supervised sessions per week for 12 months. The primary outcome was SBP at 12 months obtained in the office setting. Secondary outcomes included SBP at 6 months and DBP at 6 and 12 months obtained in the office setting and 24-hour ambulatory BP at 12 months. Of the 1189 patients screened, 342 (mean [SD] age, 49.3 [11.9] years; 166 men [48.5%] and 176 women [51.5%]) were randomized to 1 of 2 intervention groups: 173 to Tai Chi and 169 to aerobic exercise. At 12 months, the change in office SBP was significantly different between groups by -2.40 (95% CI, -4.39 to -0.41) mm Hg (P = .02), with a mean (SD) change of -7.01 (10.12) mm Hg in the Tai Chi group vs -4.61 (8.47) mm Hg in the aerobic exercise group. The analysis of office SBP at 6 months yielded similar results (-2.31 [95% CI, -3.94 to -0.67] mm Hg; P = .006). Additionally, 24-hour ambulatory SBP (-2.16 [95% CI, -3.84 to -0.47] mm Hg; P = .01) and nighttime ambulatory SBP (-4.08 [95% CI, -6.59 to -1.57] mm Hg; P = .002) were significantly reduced in the Tai Chi group compared with the aerobic exercise group. In this study including patients with prehypertension, a 12-month Tai Chi intervention was more effective than aerobic exercise in reducing SBP. These findings suggest that Tai Chi may help promote the prevention of cardiovascular disease in populations with prehypertension. Chinese Clinical Trial Registry Identifier: ChiCTR1900024368.

Effect of vitamin B2, vitamin C, vitamin D, vitamin E and folic acid in adults with essential hypertension: a systematic review and network meta-analysis

ObjectivesThe objective of the current study is to compare the treatment effects of different vitamins on essential hypertension to provide an initial basis for developing evidence-based practices.DesignSystematic review and network...

Agreement Between Guideline Thresholds Using an "All-in-One" Device to Measure Office, Home, and Ambulatory Blood Pressures.

Blood pressure (BP) thresholds for diagnosing and managing hypertension vary for office, home, and ambulatory readings, and between guideline documents. This analysis determined corresponding office, home, and ambulatory BP thresholds using baseline data from the HI-JAMP (Home-Activity Information and Communication Technology-Based Japan Ambulatory Blood Pressure Monitoring Prospective) study, which used a validated "all-in-one" BP monitoring device. Data from 2322 treated patients with hypertension who underwent office BP measurement, then 24-hour ambulatory BP monitoring, then home BP monitoring for 5 days were analyzed. Corresponding BP thresholds for office, home, and ambulatory measurements were determined using Deming regression. Values equivalent to office systolic BP (SBP) of 120 and 140 mm Hg were as follows: 115.9 and 127.7 mm Hg for 24-hour ambulatory SBP; 120.8 and 134.0 mm Hg for daytime ambulatory SBP; 104.9 and 117.9 mm Hg for nighttime ambulatory SBP; and 122.0 and 134.2 mm Hg for morning-evening average home SBP. Deming regression showed that morning-evening average home SBP and daytime ambulatory SBP were almost the same (home SBP=0.99×daytime ambulatory SBP+0.27 mm Hg; r=0.627). Morning-evening average home SBP values of 120 and 135 mm Hg were equivalent to daytime ambulatory SBP values of 119.1 and 133.9 mm Hg, respectively. A home SBP threshold of 130 mm Hg corresponded to 24-hour and nighttime ambulatory SBP values of 123.5 and 113.6 mm Hg, whereas a home SBP threshold of 135 mm Hg corresponded to 24-hour and nighttime ambulatory SBP values of 128.0 and 119.2 mm Hg. Ambulatory and home BP thresholds in this analysis were similar to those proposed by existing guidelines. The similarity between the home BP and daytime ambulatory BP thresholds was a clinically relevant finding.

Effect of Dietary Sodium on Blood Pressure

Dietary sodium recommendations are debated partly due to variable blood pressure (BP) response to sodium intake. Furthermore, the BP effect of dietary sodium among individuals taking antihypertensive medications is understudied. To examine the distribution of within-individual BP response to dietary sodium, the difference in BP between individuals allocated to consume a high- or low-sodium diet first, and whether these varied according to baseline BP and antihypertensive medication use. Prospectively allocated diet order with crossover in community-based participants enrolled between April 2021 and February 2023 in 2 US cities. A total of 213 individuals aged 50 to 75 years, including those with normotension (25%), controlled hypertension (20%), uncontrolled hypertension (31%), and untreated hypertension (25%), attended a baseline visit while consuming their usual diet, then completed 1-week high- and low-sodium diets. High-sodium (approximately 2200 mg sodium added daily to usual diet) and low-sodium (approximately 500 mg daily total) diets. Average 24-hour ambulatory systolic and diastolic BP, mean arterial pressure, and pulse pressure. Among the 213 participants who completed both high- and low-sodium diet visits, the median age was 61 years, 65% were female and 64% were Black. While consuming usual, high-sodium, and low-sodium diets, participants' median systolic BP measures were 125, 126, and 119 mm Hg, respectively. The median within-individual change in mean arterial pressure between high- and low-sodium diets was 4 mm Hg (IQR, 0-8 mm Hg; P < .001), which did not significantly differ by hypertension status. Compared with the high-sodium diet, the low-sodium diet induced a decline in mean arterial pressure in 73.4% of individuals. The commonly used threshold of a 5 mm Hg or greater decline in mean arterial pressure between a high-sodium and a low-sodium diet classified 46% of individuals as "salt sensitive." At the end of the first dietary intervention week, the mean systolic BP difference between individuals allocated to a high-sodium vs a low-sodium diet was 8 mm Hg (95% CI, 4-11 mm Hg; P < .001), which was mostly similar across subgroups of age, sex, race, hypertension, baseline BP, diabetes, and body mass index. Adverse events were mild, reported by 9.9% and 8.0% of individuals while consuming the high- and low-sodium diets, respectively. Dietary sodium reduction significantly lowered BP in the majority of middle-aged to elderly adults. The decline in BP from a high- to low-sodium diet was independent of hypertension status and antihypertensive medication use, was generally consistent across subgroups, and did not result in excess adverse events. ClinicalTrials.gov Identifier: NCT04258332.

Abstract 14531: Higher Urban Health Index is Associated With Lower Ambulatory Blood Pressure in People Living in Southeast United States

Introduction: Hypertension is common in the Southeastern (SE) United States (US), which increases the risk of heart attack, stroke and other serious health problems. Ambulatory blood pressure (ABP) monitoring is the gold standard for diagnosing hypertension and provides better information on cardio- and cerebrovascular risk than office blood pressure (BP). However, the role of social determinants of health (SDOH) and their influence on BP elevation has been scarcely examined on a neighborhood level. The Urban Health Index (UHI), developed by the World Health Organization, has the potential to measure disparities in SDOH at the small areal level and examine inequalities in health outcomes. Hypothesis: Higher UHI is associated with lower blood pressure. Methods: We analyzed data using a longitudinal cohort established in 1989 with 724 individuals (age 5-16 in 1989, 50.8% females, 47.1% African Americans) from the Central Savannah River Area. A census tract level UHI was calculated using indicators of employment, income, and educational attainment. The UHI is a unitless and continuous measure (between 0 and 1). The relationship between UHI (2000 and 2010 data) and ABP was examined using a linear regression model, adjusted for age, sex, race, and family socioeconomic status. Results: Higher UHI was associated with lower ABP, with a 3.15 mmHg and 2.72 mmHg drop in 24-hour systolic and diastolic ABP with 1 unit increase in UHI, respectively (2000 data; p=0.010; p=0.020). The 2010 data showed similar trends, with an increase in UHI linked to a 2.66 mmHg decrease in mean 24-hour systolic ABP (P=0.042), with the diastolic ABP reduction (1.74 mmHg) in the same direction though not statistically significant (p=0.088). Conclusions: This is one of the first studies to delineate the correlation of ABP with UHI. Our results show that a higher UHI is associated with lower systolic and diastolic ABP, underscoring the influence of aggregate indicators of SDOH on individual health outcomes. Our results support the utility of the UHI as a tool to inform health policymakers on disparities on a sub-county level thereby informing targeted interventions to address these disparities.

Abstract 13660: Endovascular Ultrasound Renal Denervation for Resistant Hypertension: A Systematic Review and Meta-Analysis of Randomized Sham-Controlled Trials

Background: Radiofrequency renal denervation (RDN) is used as a treatment for resistant hypertension, although its efficacy is still under evaluation. Similarly, ultrasound RDN, a less invasive technique, has yielded inconsistent results in this population. Hypothesis: Ultrasound RDN may lower blood pressure in patients with resistant hypertension. Aims: To compare the efficacy of ultrasound RDN versus a sham procedure in treating resistant hypertension. Methods: We systematically searched PubMed, Cochrane Library, and Embase in May 2023 to include randomized sham-controlled trials assessing the efficacy of ultrasound RDN. Statistical analyses were performed using Review Manager 5.4.1 using generic inverse variance weighting to pool mean ± standard deviation and least square mean ± standard error. Results: We included three studies comprising 323 patients with resistant hypertension on ≥ three antihypertensive medications, of whom 51.7% were randomized to RDN. Follow-up at analysis ranged from 8 to 24 weeks. There were no significant differences between groups in terms of change from baseline in 24-hour ambulatory systolic blood pressure (SBP; MD -2.15 mmHg; 95% -5.07, 0.76; p=0.15; Fig. 1A), 24-hour ambulatory diastolic blood pressure (DBP; MD -1.19 mmHg; 95% CI -2.91, 0.53; p=0.18; Fig. 1B) or office SBP (MD -1.71 mmHg; 95% CI -9.62, 6.20; p=0.67; Fig. 1C). Conclusion: In this meta-analysis, ultrasound RDN did not significantly reduce blood pressure in patients with resistant hypertension as compared with a sham procedure.

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

BackgroundRenal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. ObjectivesThis trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. MethodsSPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. ResultsThe treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; −6.5 ± 10.7 mm Hg) and sham control group (n = 131; −4.5 ± 10.3 mm Hg) was −1.9 mm Hg (95% CI: −4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: −0.03 mm Hg [95% CI: −2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: −4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. ConclusionsThere was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775)

Efficacy and Safety Comparative of Sacubitril/Valsartan vs. Olmesartan in the Treatment of hypertension: A Meta-analysis of RCTs.

Sacubitril/valsartan (LCZ696) is a widely used drug for hypertension in Asia, popular for its efficacy and safety. However, there has been no comprehensive literature review comparing it with olmesartan. This meta-analysis compared the antihypertensive and adverse effects of sacubitril/valsartan and olmesartan. We conducted a comprehensive search of Pubmed, Web of Science, Embase, Cochrane Library, and ClinicalTrials.gov databases to identify eligible randomized controlled trials (RCTs). The data were then analyzed and processed using Revman 5.4 and Stata SE14 software. Six RCTs with 4,127 patients were identified, showing that LCZ696 had better blood pressure control than olmesartan; mean sitting systolic and diastolic blood pressure, sitting pulse pressure, 24-hour ambulatory systolic blood pressure, and 24-hour ambulatory diastolic blood pressure were significantly decreased with LCZ696 compared with olmesartan. No significant difference between LCZ696 and olmesartan was observed in the occurrence of the majority of adverse events, with a decreased probability of headache in patients with sacubitril/valsartan compared with olmesartan. The subgroup analysis showed treatment with 400 mg/d LCZ696 was better than olmesartan in reducing serious adverse events. Sacubitril/valsartan was better than olmesartan in controlling blood pressure in patients with hypertension, with relatively higher safety.

Changes in blood pressure after catheter-based renal denervation in South Africa.

Renal denervation (RDN) is an interventional treatment for patients with uncontrolled hypertension. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, world-wide registry designed to assess the safety and efficacy of RDN. We evaluated the outcomes in South African patients in the GSR over 12 months. Eligible patients with hypertension had a daytime mean blood pressure (BP) > 135/85 mmHg or night-time mean BP > 120/70 mmHg. Office and 24-hour ambulatory systolic BP reduction and adverse events over 12 months were evaluated. South African patients (n = 36) in the GSR had a mean age of 54.4 ± 9.9 years with a median of four prescribed antihypertensive medication classes. At 12 months, mean changes in office and 24-hour ambulatory systolic BP were -16.9 ± 24.2 and -15.3 ± 18.5 mmHg, respectively, with only one adverse event recorded. RDN safety and efficacy in South African patients were consistent with world-wide GSR results.

CORRELATION BETWEEN CLINIC AND AMBULATORY BLOOD PRESSURE MEASUREMENT

Objective: Blood pressure (BP) measurements taken in the clinic provide limited information about the BP load. Ambulatory blood pressure monitoring (ABPM) provide a more comprehensive assessment of blood pressure over the course of a day. This study examined the correlation between clinic and ambulatory BP measurements. Design and method: We collated clinic and 24 hour ambulatory BP data of 100 patients aged &gt; 18 years from the outpatient cardiology clinic of Mohamed Taher Maamouri University hospital in Nabeul (n = 100) over a six months period (July-December 2021). Laying of ABPM was performed using a Bravo Mini validated device from Sun Tech Medical. We used the Pearson correlation coefficient (r) to measure the strength of the relationship between these two measurements methods. Results: The mean age of our population was 59.14±13.12 years (range 21-92 years), composed of 47 women and 53 men. The most frequent reason for carrying out ABPM was the monitoring of hypertensive patients in 84% of cases, 16% were done to confirm the diagnosis of hypertension. ABPM confirmed the diagnosis of hypertension in 62.5% and detected 18.75% isolated nocturnal hypertension in patients with suspected hypertension and 14.3% masked uncontrolled nocturnal hypertension in hypertensive patients. Concordance was found in 66% of cases between clinic measurement and the 24-hour ABPM data. There was a weak correlation between clinic systolic BP and 24-hour ambulatory systolic BP (P &lt;0.001; r = 0.349; Curve A) and moderate correlation between clinic diastolic BP and 24-hour ambulatory diastolic BP (P &lt;0.001; r = 0.566; Curve B). Conclusions: The correlation between these two methods isn’t important mainly explained by variation of BP especially at night detected by ABPM which remains the reference method for diagnosing and monitoring hypertension

Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults

Uncontrolled hypertension (ie, a 24-hour ambulatory systolic blood pressure of ≥130 mm Hg and diastolic blood pressure of ≥80 mm Hg or clinic systolic blood pressure of ≥140 mm Hg and diastolic blood pressure of ≥90 mm Hg) in young adults is a US public health burden. To evaluate the effect of a telephone coaching and blood pressure self-monitoring intervention compared with usual care on changes in systolic and diastolic blood pressures and behaviors at 6 and 12 months. This randomized clinical trial included male and female participants aged 18 to 39 years with uncontrolled hypertension confirmed by 24-hour ambulatory blood pressure testing. This was a geographically diverse, multicentered study within 2 large, Midwestern health care systems. Data were collected from October 2017 to February 2022 and analyzed from February to June 2022. The My Hypertension Education and Reaching Target (MyHEART) intervention consisted of telephone coaching every 2 weeks for 6 months, with home blood pressure monitoring. Control participants received routine hypertension care. The co-primary clinical outcomes were changes in 24-hour ambulatory and clinic systolic and diastolic blood pressure at 6 and 12 months. The secondary outcomes were hypertension control (defined as ambulatory systolic blood pressure <130 mm Hg and diastolic blood pressure <80 mm Hg or clinic systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and changes in hypertension self-management behavior. A total of 316 participants were randomized (159 to the control group and 157 to the intervention group) from October 2017 to December 2020. The median (IQR) age was 35 (31-37) years, 145 of 311 participants (46.6%) were female, and 166 (53.4%) were male; 72 (22.8%) were Black, and 222 (70.3%) were White. There were no differences in baseline characteristics between groups. There was no significant difference between control and intervention groups for mean 24-hour ambulatory systolic or diastolic blood pressure or clinic systolic or diastolic blood pressure at 6 or 12 months. However, there was appreciable clinical reduction in blood pressures in both study groups (eg, mean [SD] change in systolic blood pressure in intervention group at 6 months, -4.19 [9.77] mm Hg; P < .001). Hypertension control did not differ between study groups. Participants in the intervention group demonstrated a significant increase in home blood pressure monitoring at 6 and 12 months (eg, 13 of 152 participants [8.6%] checked blood pressure at home at least once a week at baseline vs 30 of 86 [34.9%] at 12 months; P < .001). There was a significant increase in physical activity, defined as active by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, in the intervention group at 6 months (69 of 100 [69.0%] vs 51 of 104 [49.0%]; P = .004) but not at 12 months (49 of 86 [57.0%] vs 49 of 90 [54.4%]; P = .76). There was a significant reduction in mean (SD) sodium intake among intervention participants at 6 months (3968.20 [1725.17] mg vs 3354.72 [1365.75] mg; P = .003) but not 12 months. There were no significant differences in other dietary measures. The MyHEART intervention did not demonstrate a significant change in systolic or diastolic blood pressures at 6 or 12 months between study groups; however, both study groups had an appreciable reduction in blood pressure. Intervention participants had a significant reduction in dietary sodium intake, increased physical activity, and increased home blood pressure monitoring compared with control participants. These findings suggest that the MyHEART intervention could support behavioral changes in young adults with uncontrolled hypertension. ClinicalTrials.gov Identifier: NCT03158051.

Effect of renal denervation for patients with isolated systolic hypertension: a systematic review and meta-analysis.

Renal denervation (RDN) is a promising treatment based on catheter intervention for patients with refractory hypertension. However, the effect in patients with isolated systolic hypertension (ISH) remains controversial. The aim of this meta-analysis was to determine the blood pressure lowing effect of RDN in patients with ISH compared with combined systolic/diastolic hypertension (CH) patients. PubMed, Embase, Cochrane and ClinicalTrials.gov were searched for prospective clinical studies that included RDN. The outcomes of interest were the change of 24-hour ambulatory systolic blood pressure (SBP) from baseline. We used the fixed effects model to calculate weighted mean difference (WMD) with 95% confidence interval (CI). Six trials were included, with 1405 participants, including 597 patients with ISH and 808 patients with CH. Mean follow-up was five months. The reduction of 24-hour ambulatory SBP was significantly greater for the CH patients than the ISH patients (WMD = 3.89, 95% CI: 2.32-5.45, P < 0.0001). RDN also showed a greater reduction in office SBP in the CH patients compared to the ISH patients (WMD = 10.24, 95% CI: 4.24-15.74, P = 0.0003). And the effect was independent of age, length of follow-up, and ablation device. RDN provides superior blood pressure control in the CH patients compared with the ISH patients, and the CH patients may be the best suitable population for which RDN is indicated.

Regulatory effect of dietary nitrate on blood pressure: a meta-analysis of randomized controlled trials.

Hypertension is the leading risk factor for global disease burden. Many clinical studies have reported that dietary inorganic nitrate can affect blood pressure. In this study, the PubMed, Embase, and Cochrane Library databases were searched for relevant literature published before December 2021 to explore the preventive and therapeutic effects of inorganic nitrate on hypertension. Two reviewers evaluated the randomized controlled trials of inorganic nitrates. This study included a total of 19 articles. The analyzed outcomes of the study were systolic, diastolic and mean arterial blood pressures as well as 24-hour ambulatory blood pressure. RevMan 5.4 was used to conduct meta-analysis. In the healthy population, inorganic nitrate lowered systolic blood pressure (-2.42 mmHg, 95% confidence intervals (CI) [-4.28, -0.57]; P = 0.01) but not diastolic blood pressure (-0.58 mmHg, 95% CI [-1.84, 0.68]; P = 0.36) or mean arterial pressure (-1.01 mmHg, 95% CI [-3.55, 1.54]; P = 0.44). However, in the hypertensive population, inorganic nitrates did not lower systolic blood pressure (-0.82 mmHg, 95% CI [-2.53, 0.90]; P = 0.35), diastolic blood pressure (-0.03 mmHg, 95% CI [-1.35, 1.30]; P = 0.97), 24-hour ambulatory systolic blood pressure (-0.22 mmHg, 95% CI [-1.50, 1.94]; P = 0.8), or 24-hour ambulatory diastolic blood pressure (-0.33 mmHg, 95% CI [-2.03, 1.37]; P = 0.7). In conclusion, inorganic nitrate can mildly reduce systolic blood pressure in healthy people, but does not have a lowering effect on blood pressure in patients with hypertension. Further research is required to obtain more definitive data and prove the link between inorganic nitrate and blood pressure.

Should we CLICK on chlorthalidone for treatment-resistant hypertension in chronic kidney disease?

Treatment-resistant hypertension is common among patients with advanced chronic kidney disease (CKD). In people with preserved kidney function, spironolactone is an evidence-based treatment. However, the risk for hyperkalemia limits its use in people with more advanced CKD. In the Chlorthalidone in Chronic Kidney Disease (CLICK) trial, 160 patients with stage 4 CKD and poorly controlled hypertension as confirmed by 24-hour ambulatory blood pressure (ABP) monitoring were randomly assigned to either placebo or chlorthalidone 12.5mg daily in a 1:1 ratio stratified by prior loop diuretic use. The primary endpoint was the change in 24-hour systolic ABP from baseline to 12 weeks. The trial showed a treatment-induced reduction of 24-hour systolic ABP by 10.5mmHg. Of the 160 patients randomized, 113 (71%) had resistant hypertension, of which 90 (80%) were on loop diuretics and the mean number of antihypertensive medications prescribed was 4.1 (standard deviation 1.1). In this subgroup of patients with treatment-resistant hypertension, the adjusted change from baseline to 12weeks in the between-group difference in 24-hour systolic ABP was -13.9mmHg (95% CI -19.4 to -8.4; P<.0001). Furthermore, compared with placebo, the urine albumin:creatinine ratio in the chlorthalidone group at 12weeks was 54% lower (95% CI -65 to -40). Following randomization, hypokalemia, reversible increases in serum creatinine, hyperglycemia, dizziness, orthostatic hypotension and hyperuricemia occurred more frequently in the chlorthalidone group. Chlorthalidone has the potential to improve BP control among patients with advanced CKD and treatment-resistant hypertension. However, caution is advised when treating patients, especially when they are on loop diuretics.

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.

PMON265 First Ever Placebo-Controlled Randomised Study of Testosterone on Ambulatory Blood Pressure and Heart Rate in Hypogonadal Men With Uncontrolled Type 2 Diabetes – STRIDE Study

Abstract Background Testosterone has been historically believed to increase blood pressure(BP) and hence bad for heart despite no convincing evidence to prove this. Self-administered use of anabolic steroids has adverse cardiac effects including hypertension. Many RCTs that have looked at the effect of TRT have been BP measurements using mercury sphygmomanometer. Our study is the first RCT looking at the effect of testosterone on ambulatory BP in patients with type 2 diabetes and hypogonadism. Research design and methods: This is a randomised double blinded placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido®) administered every 12 weeks in 65 hypogonadal men with poorly-controlled diabetes. Phase 1 patients were randomly assigned to either treatment or placebo arm for 6 months of TRT. Phase 2 was an open-labelled phase for 6 months and patients on placebo moved on to the treatment group wherein patients in the treatment group continued. Diurnal Ambulatory-BP measurements were performed with Spacelabs 90217 mounted on the non-dominant upper arm over 24-hours. Results Mean age of the cohort was 59(42-77)years. 55.4% of the patients had hypertension at baseline. Baseline characteristics were comparable between active/placebo groups apart from cardiovascular disease and hypertension which were significantly higher in the active group compared to placebo group (n=28 vs n=18, p=0.05), (n=23 vs n=13, p=0.008) respectively. There was no significant difference in 24-hours ambulatory average SBP or DBP before and after TRT for 6 months (SBP p=0.407, DBP p=0.649). There were no significant changes in average daytime or night-time SBP (p=0.291), (p=0.295) respectively or average daytime DBP (p=0.566) or night-time DBP (p=0.879) either. There was no significant difference in the total average heart rate and day time average heart rate however night time average heart rate showed a significant reduction of around 4 beats/minute (p=0.046) between the two groups at 6 months. There was no significant difference in the values for the above parameters in the normotensive group (average baseline ambulatory BP≤ 140/90 mm of Hg) and hypertensive group (≥ to 140/90 mm of Hg) either. There was no change in antihypertensive medications in the first 6 months. Mean 24-hour ambulatory BP components were compared at 0, 3, 6, 9 and 12 months for participants in the active group before and after treatment with testosterone undecanoate. There was no significant change in the total, day or night-time systolic or diastolic BP levels before and after the treatment. Conclusions Our study concludes that testosterone given as a replacement hormone in hypogonadal patients with type 2 diabetes does not increase 24-hour ambulatory systolic or diastolic BP. Our study also shows that testosterone causes a decrease in average night-time heart rate of 4 to 5 beats/minute and the cause and significance of such a decrease needs further detailed evaluation. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.