Reduction In Office Blood Pressure Research Articles

Sacubitril/valsartan reversal of left ventricular remodeling is associated with improved hemodynamics in resistant hypertension

BackgroundSacubitril/valsartan (S/V) has been shown to be an effective antihypertensive drug combination. However, its therapeutic effects on blood pressure (BP) and hemodynamics as well as left ventricular (LV) remodeling in resistant hypertension (RHTN) remain unclear. MethodsEighty-six patients completed this self-control study, during which olmesartan was administered within the first 8 weeks (phase 1) followed by S/V within the second 8 weeks (phase 2), with nifedipine and hydrochlorothiazide taken as background medications. Office BP, echocardiography and hemodynamics assessment using impedance cardiography were performed at baseline, the eighth and sixteenth weeks. ResultsThe reduction in office BP was larger in phase 2 than in phase 1 (19.59/11.66 mmHg vs. 2.88/1.15 mmHg). Besides, the treatment in phase 2 provided greater reductions in systemic vascular resistance index (SVRI) and thoracic blood saturation ratio (TBR), with differences between two phases of -226.59 (-1212.80 to 509.55) dyn·s/cm5/m2 and -0.02 (-0.04 to 0.02). Switching from olmesartan to S/V also significantly reduced E/E`, LV mass index, LV end-diastolic volume index and LV end-systolic volume index (all P < 0.05). Decreases in AS, SVRI and TBR were correlated with changes in indicators of LV remodeling (all P < 0.05). And the correlation still remained even after adjusting for confounders including changes in BP. ConclusionsSwitching from olmesartan to S/V effectively lowered BP and reversed ventricular remodeling in RHTN. In addition, hemodynamics improvement was also observed. Changes in hemodynamics played an important role in reversing LV remodeling of S/V, which were independent of its antihypertensive effect.

Prediction of endogenous mineralocorticoid receptor activity by depressor effects of mineralocorticoid receptor antagonists in patients with primary aldosteronism.

Patients with primary aldosteronism have an increased risk of developing cardiovascular disease. The response to mineralocorticoid receptor antagonists varies among individuals, indicating diverse mineralocorticoid receptor activities in these patients. This study explored the factors linked to the efficacy of blood pressure reduction through mineralocorticoid receptor antagonists in patients with primary aldosteronism. We examined the relationship between the reduction in blood pressure and patient characteristics in a group of 41 patients with primary aldosteronism (24 males, mean age 55 ± 13 years, including 34 patients diagnosed with bilateral primary aldosteronism) before and after undergoing treatment with mineralocorticoid receptor antagonists. Significant reductions in office blood pressure were observed 3 and 6 months after treatment initiation. Single correlation analyses showed that the urinary chloride-to-potassium ratio displayed the strongest positive association with blood pressure reduction, surpassing plasma aldosterone concentration, plasma renin activity, and urinary sodium-to-potassium ratio, at 3 and 6 months. Multiple correlation analyses revealed a consistent and independent positive correlation between the urinary chloride-to-potassium ratio and blood pressure reduction at 3 and 6 months. The optimal threshold for the urinary chloride-to-potassium ratio with respect to its ability to lower blood pressure, was determined as 3.18. These results imply that the urinary chloride-to-potassium ratio may be independently associated with the effectiveness of blood pressure reduction facilitated by mineralocorticoid receptor antagonists. Moreover, it could potentially serve as a valuable predictor of the effectiveness of these agents and function as an indicator of endogenous mineralocorticoid receptor activity in patients with primary aldosteronism.

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.

The SPYRAL HTN-ON MED trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44). Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.

Blood pressure reduction after renal denervation in patients with or without chronic kidney disease.

Renal denervation (RDN) has emerged as an adjacent option for the treatment of hypertension. This analysis of the Erlanger registry aimed to compare the blood pressure (BP)-lowering effects and safety of RDN in patients with and without chronic kidney disease (CKD). In this single-center retrospective analysis, 47 patients with and 127 without CKD underwent radiofrequency-, ultrasound- or alcohol-infusion-based RDN. Office and 24-h ambulatory BP and estimated glomerular filtration rate (eGFR) were measured at baseline, and after 6 and 12months. A total of 174 patients with a mean age of 59.0±10years were followed up for 12months. At baseline, mean eGFR was 55.8±21mL/min/1.73 m2 in patients with CKD and 87.3±13mL/min/1.73 m2 in patients without CKD. There was no significant eGFR decline in either of the groups during 12months of follow-up. In patients without CKD, office systolic and diastolic BP were reduced by -15.3±17.5/-7.9±10.8mmHg 6months after RDN and by -16.1±18.2/-7.7±9.6mmHg 12months after RDN. In patients with CKD, office systolic and diastolic BP were reduced by -10.7±24.0/-5.8±13.2mmHg 6months after RDN and by -15.1±24.9/-5.9±12.9mmHg 12months after RDN. Accordingly, in patients without CKD, 24-h ambulatory systolic and diastolic BP were reduced by -7.2±15.8/-4.9±8.8mmHg 6months after RDN and by -9.0±17.0/-6.2±9.8mmHg 12months after RDN. In patients with CKD, 24-h systolic and diastolic BP were reduced by -7.4±12.9/-4.2±9.9mmHg 6months after RDN and by -8.0±14.0/-3.6±9.6mmHg 12months after RDN. There was no difference in the reduction of office and 24-h ambulatory BP between the two groups at any time point (all P>.2). Similar results have been found for the 6months data. With exception of rare local adverse events, we did not observe any safety signals. According to our single-center experience, we observed a similar reduction in 24-h, day and night-time ambulatory BP as well as in-office BP in patients with and without CKD at any time point up to 12months. We conclude that RDN is an effective and safe treatment option for patients with hypertension and CKD.

Abstract 056: Pooled, 6-month Renal Safety And Blood Pressure Reductions Using The Symplicity Spyral Radiofrequency Renal Denervation Catheter

Background: Renal denervation (RDN) targets the sympathetic nervous system to lower blood pressure (BP). Impact on long-term renal function after RDN is less well known. We report 6-month renal safety and BP reductions after RDN from the largest database, using the latest generation, multi-electrode, radiofrequency (RF) Symplicity Spyral™ catheter. Methods: A broad spectrum of patients with hypertension were enrolled in the SPYRAL HTN Global Clinical Program (4 major studies; SPYRAL First-In-Man, SPYRAL HTN-OFF MED, -ON MED and Global SYMPLICITY Registry [GSR]). GSR is an all-comer registry for patients with uncontrolled hypertension, including chronic kidney disease (CKD), whereas patients enrolled in the SPYRAL HTN-OFF and -ON MED trials required to have OSBP ≥150 and &lt;180 mmHg and ODBP ≥90 mmHg. OFF MED patients were required to have a drug washout period prior to treatment and did not take drugs for the first 3 months. ON MED patients were on a stable 1-3 antihypertensive drug regimen for 6 months. All were treated with RF RDN using the Spyral catheter. We pooled reductions in office and 24-h ambulatory BP, safety outcomes include changes in the estimated glomerular filtration rate (eGFR) and renal artery stenosis incidence (&gt;70%, confirmed by angiography). Results: As of December 2022, 1,284 patients have received RF RDN with the Spyral catheter. Patients at baseline were 58±12yrs old, 37.6% female, 29.1% had type 2 diabetes, eGFR was 77.7±23.9mL/min/1.73m2, 20.7% had CKD stage 3 or higher, OSBP was 166±21mmHg and ASBP was 153±16mmHg. 6 months after RDN, OSBP changed by -14.8±22.1 (n=940; p&lt;0.001) and ASBP changed by -8.9±16.0 (n=678; p&lt;0.001). Significant diastolic BP reductions were also observed. eGFR changed by -2.0mL/min/1.73m2. There was no incidence of renal artery stenosis (&gt;70%). Conclusion: In this large, pooled population of patients receiving RF RDN using the Spyral catheter, there were significant and consistent BP reductions through 6 months. There was no incidence of renal artery stenosis, and eGFR change was consistent with the natural progression of the aging hypertensive population. These data highlight the safety and efficacy of RF RDN as an adjunctive therapy to antihypertensive drugs to treat high BP.

Abstract P406: Aprocitentan, A Novel Endothelin Receptor Antanognist, In Older Patients With Difficult-to-control Hypertension

Background: In older adults, hypertension (HTN) control can be difficult despite multiple therapies, especially in those with altered kidney function. The PRECISION study showed that aprocitentan (APRO), a dual endothelin receptor antagonist12.5 or 25 mg daily decreases blood pressure (BP) in patients (Pts) with resistant HTN. We evaluated APRO BP lowering in Pts aged ≥ 65 years. Methods: Pts had sitting unattended automated office systolic BP (SBP) ≥ 140 mmHg after switching their antihypertensives (anti-HTN) (except beta-blockers) to a standardized therapy (ST) of amlodipine, valsartan and HCTZ. Reductions in office and ambulatory BP; and safety were assessed in 3 sequential parts over a 48-week period as follows: 4-week double-blind (DB) APRO 12.5 mg, APRO 25 mg, PBO; 32-week single-blind APRO 25 mg; and 12-week DB withdrawal APRO 25 mg, PBO. Results: In PRECISION, 321 Pts were aged ≥ 65 years. Of those, 202 (63%) were obese, 115 (36%) had chronic kidney disease stage 3-4, and 209 (65%) were on ≥ 4 anti-HTN prior switching to ST.At Week 4, APRO reduced office SBP, PBO adjusted SBP is: APRO 12.5 mg -5.64 and APRO 25 mg -4.63 mmHg in Pts 65–&lt; 75 years; and APRO 12.5 mg -6.75 and APRO 25 mg -12.85 mmHg in Pts ≥ 75 years. APRO 25 mg maintained BP reduction over 32 weeks but this disappeared at Week 40 in those randomized to PBO at Week 36, PBO adjusted SBP is +5.70 mmHg in Pts 65–&lt; 75 years; +3.51 mmHg in Pts ≥ 75 years. Ambulatory BP confirmed office BP reductions with both APRO doses, particularly with APRO 25 mg on nighttime SBP at Week 4 in Pts ≥ 75 years: 12.5 mg: -8.8; 25 mg: -14.8; PBO +1.0 mmHg. At Week 4, the most frequent adverse event (AE) was peripheral edema: 7.7%, 12.9%, and 2.3% in Pts 65–&lt; 75 years, and 18.2%, 22.7%, and 3.6% in Pts ≥ 75 years, with APRO 12.5 mg, APRO 25 mg, and PBO, respectively. Edema was managed with additional diuretics. 4 Pts discontinued due to edema; none had received additional diuretics. 7 Pts (APRO 25 mg) were hospitalized for heart failure; 4 of them had switched from loop or more than one diuretic to HCTZ.No orthostatic hypotension events occurred. Conclusion: In older resistant HTN Pts, APRO added to ≥ 3 anti-HTN substantially decreased office and ambulatory BP. The most frequent AE was peripheral edema, which rarely led to treatment discontinuation.

34. Efficacy and Safety of Sacubitril Valsartan in Managing Hypertension Compared with Angiotensin Receptor Blockers: A Systematic Review and Meta-analysis

Background: Sacubitril/Valsartan has shown promising result in the management of heart failure with reduced ejection fraction patients. However, it also withhold the potential as antihypertensive agent. Thus, its effectiveness in reducing high blood pressure (BP) compared with Angiotensin Receptor Blockers (ARBs) needs to be determined. Objective: This study aimed to compare the efficacy and safety of Sacubitril/Valsartan and ARBs in managing hypertension patients. Methods: We searched for the studies from Pubmed, Proquest, Google Scholar and Cochrane Library databases which compare the BP reduction effect of Sacubitril/Valsartan and ARBs. The main outcomes were mean office and ambulatory BP reduction. The safety profile was determined by the incidence of adverse events (AEs). Results: 5114 adult patients with hypertension from 10 RCTs were included. Sacubitril/Valsartan provided significant mean reduction of office systolic BP (mean difference: –4.66; 95%CI: –5.13 to –4.20; p &lt; 0.001), office diastolic BP (mean difference: –3.23; 95%CI: –3.54 to –2.92; p &lt; 0.001), ambulatory systolic BP (mean difference: –3.42; 95%CI: –5.13 to –1.17; p &lt; 0.001), and ambulatory diastolic BP compared with ARBs (mean difference: –1.50; 95%CI: –2.15 to –0.85; p &lt; 0.001). There was no significant difference in the incidence of AEs between the two groups (RR: 1.04; 95%CI: 0.95 to 1.14; p = 0.35). The BP reduction and incidence of AEs were consistent in the subgroup analysis (Olmesartan and Valsartan treatment group), except in comparison with Olmesartan treatment group for ambulatory systolic BP parameter (mean difference: –2.62; 95% CI: –5.30 to 0.07; p: 0.06). Conclusion: Sacubitril/Valsartan is more potent in reducing BP to ARBs, with similar safety profile.

PS-P15-5: EFFECT OF SODIUM RESTRICTION ON LARGE ARTERY STIFFNESS AND DISTENSIBILITY OF SMALL ARTERIES IN HYPERTENSIVE PATIENTS: A RANDOMIZED TRIAL

Objective: Arterial stiffness is characterized by a decrease in arterial distensibility, resulting from the interaction between the extracellular matrix and cellular elements. Large and small arteries can be differently influenced by extrinsic factors, such as excessive sodium intake. This study aim to evaluate the impact of sodium restriction on large artery stiffness and distensibility of small arteries in young adults diagnosed with arterial hypertension. Methods: Randomized controlled clinical trial, including 20 hypertensive patients, aged between 30 and 59 years, followed up at the hypertension outpatient clinic of a tertiary hospital. Subjects were randomized into two groups: group 1 - low-sodium diet (2 g sodium/day); group 2 - usual diet. To analyze the stiffness and distensibility of the arteries, it was measured aortic pulse wave velocity by Complior®, elasticity of small arteries and vascular resistance by HDI®, and also through the measurement of metalloproteinase-9. For nutritional assessment it were considered blood glucose levels, 24-h urinary sodium, body mass index (BMI) and other anthropometric measurements. For nutritional intake we analized the 24-hour dietary recall. Results and Discussion: In comparison with group 2, it was observed a significant (p &lt; 0.05) reduction in office blood pressure (p = 0,037) and pulse wave velocity (p = 0,010) in group 1 subjects. Also, in group 1 it occurred reduction in blood glucose levels, BMI, waist and neck circumference. Sodium intake was significantly reduced in group 1, taking into account 24 hs urinary sodium and evaluated by dietary recall. It is worth mentioning that excessive sodium intake linked to arterial hypertension causes a remodeling process, increased oxidative stress, inflammation and fibrosis of the arteries, contributing to arterial stiffness. Regarding the distensibility of small arteries, no significant differences were found between the two groups, but the intervention period and the number of individuals in the study should be taken into account, since these factors may have influenced the results. Conclusion: Sodium restriction for a short period of time promoted reduction of arterial stiffness, in parallel to reduction in obesity parameters and blood pressure in adults diagnosed with systemic arterial hypertension.

PS-C10-3: THE EFFECT OF E HEALTH ESH APPLICATION ON BP MANAGEMENT PRELIMINARY RESULTS

Objective: Main issues in the treatment of hypertension are the low level of blood pressure (BP) control and the economic burden for health care systems. Mobile application with telemonitoring of BP could contribute to better control and lower costs by reducing office visits. This could be useful nowadays with difficult access to health system due to covid-19. The purpose of this study was to investigate if an innovative management strategy of hypertension, such as the use of ESH care application for smartphones combined with a dedicated platform, could improve hypertension control and replace frequent office visits. Design and method: 30 uncontrolled hypertensive patients, treated or untreated [mean age 53 ± 9 years, mean office BP (OBP) 146.3 ± 6.2 / 92.5 ± 9 mmHg, 53% men, 33% smokers, 23% with hypercholesterolemia] were randomized to the application assisted strategy (AAS) (17 patients), where a mobile phone application was offered to communicate home BP measurements (HBPm), or to regular office visits (13 patients). Patients BP measurements (HBPm for AAS and OBP for standard care group) were evaluated in 1 and 3 months with treatment titration if uncontrolled. In all patients OBP and ambulatory BP measurement (ABPM) were evaluated in 6 months. Results: In both groups the reduction in OBP and ABPM was significant in 6 months. In the AAS group the reduction in systolic/diastolic OBP and 24 h systolic/diastolic BP in 6 months was -26.5 ± 5.6 / -19.4 ± 8.2 mmHg (p &lt; 0,001) and -19.6 ± 7.7 / -13.8 ± 4.8 mmHg (p &lt; 0.001), respectively. In the standard care group, the reduction in systolic/diastolic OBP and 24 h systolic/diastolic BP in 6 months was -22.6 ± 9.7 / -9.6 ± 11 mmHg (p &lt; 0.005) and -18.4 ± 6.0 / - 8.8 ± 4.4 mmHg (p &lt; 0.001). In AAS group compared to standard care group there was a greater reduction in 24 h diastolic BP (-13.8 ± 4.8 mmHg vs -8.8 ± 4.4 mmHg, p = 0.016) and in diastolic OBP (-19.4 ± 8.2 mmHg vs -9.6 ± 11.0 mmHg, p = 0.04). Conclusions: The present results indicate that the monitoring of patients through a mobile health tool could be useful in hypertension management as it is correlated with better BP control compared to office visits. The trial is still enrolling patients.

S-12-1: PAST AND FUTURE OF HYPERTENSION RESEARCH

Research on hypertension has achieved, in the last few decades, important results on the pathophysiology, diagnosis and treatment of the high blood pressure (BP) condition. However, as listed in the 2018 European guidelines, several aspects remain unclarified either because they have not been explored by properly designed studies or because data remain controversial. This presentation will discuss some of the questions that represent important unmet needs for hypertension research. One, absence of randomized evidence-based trials on the benefit of antihypertensive treatment in important clinical conditions such as white coat hypertension, masked hypertension, resistant hypertension, hypertension of the very elderly people (e.g. nonagenarians) and hypertensives classifiable as frail because of the high number of comorbidities and poor life expectancy. Two, hypertension of relatively young people (e.g. &lt; 45 or 40 years) in whom low event incidence prevents the performance of event-based trials, making prevention or progression of subclinical organ damage probably the only reliable and feasible approach. Three, the benefit of funding treatment on out-of-office (ambulatory and/or home) BP either as an alternative or an addition to classical office BP reduction, a fundamental therapeutic issue never addressed in the past. Four, the BP threshold at which to start treatment in naive hypertensives and the goal BP value to try to reach in different demographic and clinical hypertension subgroups. And finally, the problem of residual risk in apparently well treated hypertensive individuals, i.e. their persistence at a risk level clearly higher than that of the control population. A final consideration will be that assessing this issue by randomized trials will probably be difficult and that future research will thus have to rely more and more frequently on observational studies which can now be based on large population data-bases that extend over many years and can, via extensive information and high quality analysis, substantially reduce the risk of the risk of confounding associated with this approach.

Patient Preferences for Pharmaceutical and Device-Based Treatments for Uncontrolled Hypertension: Discrete Choice Experiment.

Discrete choice experiment is a survey method used to understand how individuals make decisions and to quantify the relative importance of features. Using discrete choice experiment methods, we quantified patient benefit-risk preferences for hypertension treatments, including pharmaceutical and interventional treatments, like renal denervation. Respondents from the United States with physician-confirmed uncontrolled hypertension selected between treatments involving a procedure or pills, using a structured survey. Treatment features included interventional, noninterventional, or no hypertension treatment; number of daily blood pressure (BP) pills; expected reduction in office systolic BP; duration of effect; and risks of drug side effects, access site pain, or vascular injury. The results of a random-parameters logit model were used to estimate the importance of each treatment attribute. Among 400 patients completing the survey between 2020 and 2021, demographics included: 52% women, mean age 59.2±13.0 years, systolic BP 155.1±12.3 mm Hg, and 1.8±0.9 prescribed antihypertensive medications. Reduction in office systolic BP was the most important treatment attribute. The remaining attributes, in decreasing order, were duration of effect, whether treatment was interventional, number of daily pills, risk of vascular injury, and risk of drug side effects. Risk of access site pain did not influence choice. In general, respondents preferred noninterventional over interventional treatments, yet only a 2.3 mm Hg reduction in office systolic BP was required to offset this preference. Small reductions in office systolic BP would offset risks of vascular injury or drug side effects. At least a 20% risk of vascular injury or drug side effects would be tolerated in exchange for improved BP. Reduction in systolic BP was identified as the most important driver of patient treatment preference, while treatment-related risks had less influence. The results indicate that respondents would accept interventional treatments in exchange for modest reductions in systolic BP compared with those observed in renal denervation trials.

Abstract 10114: A Systematic Review, Meta-Analysis of Sham and Placebo Controlled Trials Testing Spironolactone and Renal Denervation as Treatments for Resistant Hypertension

Introduction: The most common 4 th -line treatment for resistant hypertension (RHTN) is the addition of a mineralocorticoid receptor antagonist (MRA). Renal denervation (RD) has also been investigated as a treatment option for RHTN. A lack of data on the comparative effectiveness of these two therapies poses challenges in choosing optimal treatment strategies for patients with RHTN. Methods: Placebo-controlled and sham-controlled randomized clinical trials testing spironolactone or RD as treatments for RHTN were included in this analysis. Prespecified subgroup analyses comparing the efficacy of MRA and RD were conducted for the outcomes of 24-hour blood pressure (BP) and office BP. Results: Fourteen studies (8 MRA and 6 RD) were identified that included 2,306 participants (1,414 MRA and 892 RD). Cochran risk of bias assessment showed 84% of the domains to be low risk of bias for the MRA studies and 88% of the domains to be low risk of bias for the RD studies. The raw mean difference (RMD) between MRA and placebo control was statistically significant for 24-hour systolic (SBP) (-10.59 mmHg; 95% confidence interval (CI) -12.88 to -8.31), 24-hour diastolic (DBP) (-5.03 mmHg; 95% CI -6.75 to -3.32), office SBP (-10.43 mmHg; 95% CI -12.23 to -8.63), and office DBP (-4.10 mmHg; 95% CI -5.18 to -3.02). The RMD between RD and sham control was not statistically significant for 24-hour SBP (-1.85 mmHg; 95% CI -3.88 to 0.18), 24-hour DBP (-0.67 mmHg; 95% CI -1.84 to 0.51), office SBP (-1.93 mmHg; 95% CI -5.17 to 1.31), and office DBP (-1.55 mmHg; 95% CI -3.43 to 0.33). The interaction between the subgroups was statistically significant for all analyses. Discussion: MRAs had a greater reduction in 24-hour ambulatory and office BP compared to RD among patients with RHTN. This data may help physicians s counsel their patients regarding optimal treatment options for RHTN.

Abstract 11428: A Comparison Between Endothelin Receptor Antagonists and Renal Denervation for Resistant Hypertension: A Systematic Review and Meta-Analysis of Sham and Placebo Controlled Trials

Introduction: Endothelin-1 causes vasoconstriction by activation of calcium flux in smooth muscle cells. Use of endothelin receptor antagonists (ERAs) has remained controversial. Renal denervation (RD) has also been investigated as a treatment option for resistant hypertension (RHTN). The efficacy of these two novel treatment strategies was compared. Methods: Placebo-controlled and sham-controlled randomized clinical trials testing ERA or RD as treatments for RHTN were selected. Prespecified subgroup analyses comparing the efficacy of ERA and RD were conducted for outcomes of 24-hour (hr) blood pressure (BP) and office BP. Results: Nine studies (3 ERA and 6 RD) were identified that included 1,708 participants (816 ERA and 892 RD). Cochran risk of bias assessment showed 72% of the domains to be low risk of bias for the ERA studies and 88% of the domains to be low risk of bias for the RD studies. The raw mean difference (RMD) between ERA and placebo control was statistically significant for 24-hr systolic (SBP) (-8.34 mmHg; 95% CI -11.51 to -5.81, 24-hr diastolic (DBP) (-6.77 mmHg; 95% CI -8.90 to -4.63), office SBP (-4.50 mmHg; 95% CI -6.92 to -2.08), and office DBP (-2.01 mmHg; 95% CI -2.13 to -1.88). The RMD between RD and sham control was not statistically significant for 24-hr SBP (-1.85 mmHg; 95% CI -3.88 to 0.18), 24-hr DBP (-0.67 mmHg; 95% CI -1.84 to 0.51), office SBP (-1.93 mmHg; 95% CI -5.17 to 1.31), and office DBP (-1.55 mmHg; 95% CI -3.43 to 0.33). The interaction between the treatment subgroups was statistically significant for 24-hr SBP and DBP, but not for office SBP and DBP. Discussion: ERAs had greater reduction in 24-hr and office BP compared to RD among patients with RHTN. Despite efficacy in reducing BP in RHTN, use of ERAs remains controversial given the cost and side effect profile. RD does not reduce BP among patients with RHTN. Medications are the optimal treatment for RHTN and sham controlled data showing efficacy is needed prior to widespread use and adoption of RD in RHTN.

Blood pressure reduction in higher cardiovascular risk patients in the Global SYMPLICITY Registry

Abstract Background/Introduction The Global SYMPLICITY Registry (GSR) was designed to evaluate the safety and efficacy of renal denervation (RDN) in real-world patients. Inclusion and exclusion criteria are limited to allow assessment of the effects of RDN on patients with a wide range of comorbidities. The current analysis examines blood pressure (BP) reduction after RDN in higher cardiovascular risk patients. Purpose To evaluate blood pressure reduction after RDN in higher cardiovascular risk patients in GSR. Methods GSR is a prospective all-comers registry to evaluate the safety and efficacy of RDN. Patients are enrolled in GSR and receive radiofrequency RDN using the Symplicity Flex or Symplicity Spyral catheter. Office and ambulatory BP are measured at each follow-up (3, 6, 12, 24, and 36 months). In this post-hoc analysis, changes from baseline in office and 24-hour ambulatory systolic blood pressure were assessed in patients at higher cardiovascular risk. Higher risk was defined using baseline office systolic or diastolic BP as well as additional risk factors (Figure 1). Results As of March 2021, there were 2621 patients characterized as higher cardiovascular risk in GSR. Baseline characteristics included mean age 60.7±12.1 years, 57.6% male, 37.9% type 2 diabetes, 35.8% hypocholesterolemia, 19.7% eGFR &amp;lt;60 mL/min/1.73 m2, 16.2% left ventricular hypertrophy, 10.2% previous stroke and 9.3% previous myocardial infarction. Baseline office systolic BP (OSBP) was 168.8±22.7 mmHg and baseline ambulatory systolic BP (ASBP) 155.3±18.6 mmHg. Mean OSBP reductions after RDN in this higher risk population ranged from −13.1 mmHg at 3 months to −17.5 mmHg at 24 months and −18.9 mmHg at 36 months, and mean ASBP reductions ranged from −7.8 mmHg at 3 months to −9.8 mmHg at 24 months and −9.3 mmHg at 36 months (Figure). Conclusions Higher risk patients in GSR had sustained office and ambulatory systolic BP reductions out to 3 years after catheter-based radiofrequency RDN. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

IntroductionClinical data of esaxerenone in hypertensive patients with diabetic kidney disease (DKD) are lacking. We evaluated the efficacy and safety of esaxerenone in patients with DKD and an inadequate response to blood pressure (BP)-lowering treatment.MethodsIn this multicenter, open-label, prospective study, patients were divided into urinary albumin-to-creatinine ratio subcohorts (UACR < 30, 30 to < 300, and 300 to < 1000 mg/gCr). Esaxerenone was initiated at 1.25 mg/day and followed by incremental dose escalation based on BP and serum potassium level monitoring. The treatment period was 12 weeks. The primary endpoint was change in morning home systolic BP/diastolic BP (SBP/DBP) from baseline to end of treatment (EOT). Secondary endpoints included achievement rate of target BP, change in UACR from baseline, and safety.ResultsIn total, 113 patients were enrolled. Morning home SBP/DBP significantly decreased from baseline to EOT in the total population (− 11.6/− 5.2 mmHg, both p < 0.001) and in all UACR subcohorts (all p < 0.001). The target BP achievement rate was 38.5%. Significant reductions in bedtime home and office BPs were also shown in the total population and all UACR subcohorts. UACR significantly improved from baseline to EOT in the total (− 50.9%, p < 0.001) and all UACR subcohorts (all p < 0.001). Incidence of serum potassium elevation as drug-related treatment emergent adverse events was 2.7%. The change from baseline in estimated glomerular filtration rate (eGFR) was − 4.8 mL/min/1.73 m2.ConclusionEsaxerenone demonstrated a BP-lowering effect and improved albuminuria. The effects were consistent regardless of the severity of albuminuria without clinically relevant serum potassium elevation and eGFR reduction.Clinical Trial RegistrationjRCTs06119002.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02294-z.

Antihypertensive drug treatment in white-coat hypertension: data from the Plaque HYpertension Lipid-Lowering Italian Study.

Little evidence is available on whether antihypertensive treatment lowers cardiovascular risk in white-coat hypertension (WCH). Protection might be indirectly inferred, however, from the blood pressure (BP) effects of treatment as in trials BP reduction is linearly related to outcome reduction. We analyzed the effect of antihypertensive treatment on office and ambulatory BP in WCH using data from the Plaque HYpertension Lipid-Lowering Italian Study (PHYLLIS). : Office and ambulatory blood pressure were measured in 470 hypertensive patients randomized to fosinopril or hydrochlorothiazide alone or combined with a statin before treatment and at 6 month or yearly intervals during 2.6 years of follow-up. Patients were divided into two groups according to whether before randomization to treatment office and 24-h mean BP were elevated (sustained hypertension) or office BP was elevated but 24-h BP values were normal (WCH). : In both sustained hypertension and WCH antihypertensive treatment was associated with an early marked office BP reduction, which persisted virtually unchanged throughout the treatment period. In contrast, 24-h (and day and night) BP showed a marked and persistent treatment-related fall in sustained hypertension but no change in WCH. The results were similar when data were separately analyzed in patients under fosinopril or diuretic, with or without statin treatment. : In WCH, antihypertensive treatment can effectively and durably reduce office BP. This reduction is accompanied by the inability to lower ambulatory BP from the normal values characterizing this condition at baseline. This appears to be unrelated to the type of treatment employed.

POSTEXERCISE HYPOTENSION IN AFRICAN AND ASIAN POPULATIONS: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Hypertension is the global leading risk factor for the development of cardiovascular diseases, with the highest prevalence in Asian and African populations. Post-exercise hypotension (PEH) defined as a sustained reduction in blood pressure (BP) after a single bout of exercise is an important physiological phenomenon in BP management. However, little is known about PEH in non-Caucasian populations.Therefore, we aim to systematically summarize the effects of a single bout of aerobic exercise on BP in non-Caucasian populations.We searched the MEDLINE database identifying randomized controlled trials investigating the effect of a single bout of aerobic exercise on BP in African or Asian populations published in a peer reviewed journal up to August 2021. A meta-analysis was performed to estimate random effect sizes within 95% of confidence intervals.We identified 10 aerobic exercise trials in individuals of Asian origin (n = 156; mean age: 27.05 years: 72% male) and 11 aerobic exercise trials involving individuals of African origin (n = 112; mean age: 41.37 years; 62% male). Non-significant reductions in office BP at 30 minutes (-1.18 [-9.98, 7.62]/-1.29 [-7.32, 4.74] mmHg) and 60 minutes postexercise (-1.80 [-9.98, 7.62]/ -1.28 [-6.03, 3.46] mmHg) were observed in the African group. Similar to the African group, non-significant reductions in office BP at 30 minutes (-2.17 [-6.78, 2.43] / -0.82 [-2.41, 0.77] mmHg) postexercise were observed in the Asian group. No effect was found on 24h-systolic BP postexercise, but 24h-diastolic BP reduced significantly (-1.89 [-3.47, -0.31] mmHg) in the African group.Except for a small, though statistically significant effect on 24h-DBP in the African group, a single bout of aerobic exercise does not seem to cause clinically relevant PEH in the African and Asian populations. It should be acknowledged that the available studies on PEH applying aerobic exercise are limited and there is a lack of data on PEH following isometric and resistance exercise in these populations. This systematic review and meta-analysis is a call for more research on exercise therapy in non-Caucasians.

BLOOD PRESSURE MANAGEMENT WITH THE ESH CARE APP – PRELIMINARY RESULTS

Main issues in the treatment of hypertension are the low level of blood pressure (BP) control and the economic burden for health care systems. Mobile application with telemonitoring of BP could contribute to better control and lower costs by reducing office visits. This could be useful nowadays with difficult access to health system due to covid-19. The purpose of this study was to investigate if an innovative management strategy of hypertension, such as the use of ESH care application for smartphones combined with a dedicated platform, could improve hypertension control and replace frequent office visits.30 uncontrolled hypertensive patients, treated or untreated [mean age 53 ± 9 years, mean office BP (OBP) 146.3 ± 6.2 / 92.5 ± 9 mmHg, 53% men, 33% smokers, 23% with hypercholesterolemia] were randomized to the application assisted strategy (AAS) (17 patients), where a mobile phone application was offered to communicate home BP measurements (HBPm), or to regular office visits (13 patients). Patients' BP measurements (HBPm for AAS and OBP for standard care group) were evaluated in 1 and 3 months with treatment titration if uncontrolled. In all patients OBP and ambulatory BP measurement (ABPM) were evaluated in 6 months.In both groups the reduction in OBP and ABPM was significant in 6 months. In the AAS group the reduction in systolic/diastolic OBP and 24 h systolic/diastolic BP in 6 months was -26.5 ± 5.6 / -19.4 ± 8.2 mmHg (p < 0,001) and -19.6 ± 7.7 / -13.8 ± 4.8 mmHg (p < 0.001), respectively. In the standard care group, the reduction in systolic/diastolic OBP and 24 h systolic/diastolic BP in 6 months was -22.6 ± 9.7 / -9.6 ± 11 mmHg (p < 0.005) and-18.4 ± 6.0 / - 8.8 ± 4.4 mmHg (p < 0.001). In AAS group compared to standard care group there was a greater reduction in 24 h diastolic BP (-13.8 ± 4.8 mmHg vs -8.8 ± 4.4 mmHg, p = 0.016) and in diastolic OBP (-19.4 ± 8.2 mmHg vs -9.6 ± 11.0 mmHg, p = 0.04).The present results indicate that the monitoring of patients through a mobile health tool could be useful in hypertension management as it is correlated with better BP control compared to office visits. The trial is still enrolling patients.

20 THE CLINICAL SAGA OF RENAL DENERVATION IN UNCONTROLLED HYPERTENSION: AN UPDATED META-ANALYSIS OF RANDOMIZED SHAM-CONTROLLED TRIALS

Background: Renal denervation (RDN) with catheter ablation has shown promising yet conflicting results in the management of uncontrolled hypertension. With the availability of recent randomized sham-controlled trials, we decided to perform an updated meta-analysis. Objective: To examine the utilization of renal denervation in patients with uncontrolled hypertension. Method: A systematic search in electronic databases was conducted. We included randomized sham-controlled trials comparing RDN and sham procedure in patients with uncontrolled hypertension. Included studies were evaluated for risk of bias. Our outcomes of interest were 24-hour ambulatory blood pressure (BP) and office BP. We performed fixed and random-effects meta-analysis using the inverse variance method to calculate the mean difference (MD) and 95% confidence interval (CI). Result: Final analysis included 10 studies with a total of 1,571 patients. With the median follow-up period of 6 months, RDN was associated with a significant decrease in 24-hour ambulatory BP (Systolic: MD -3.50 mmHg, 95% CI -4.75, -2.25, p&lt;0.00001, I2=0.00; Diastolic: MD -1.97 mmHg, 95% CI -2.74, -1.20, p&lt;0.00001, I2=0.31) compared to sham procedure. Similiarly, office BP was reduced significantly with RDN when compared to sham procedure (Systolic: MD -4.89 mmHg, 95% CI -7.67, -2.10, p=0.04, I2=0.51; Diastolic: MD -3.07 mmHg, 95% CI -4.14, -2.00, p&lt;0.00001. I2=0.38). Further subgroup analysis showed that radiofrequency RDN was associated with a significant reduction in both 24-hour ambulatory and office BP, while ultrasound RDN was not associated with such differences. Conclusion: This updated meta-analysis suggests that RDN is associated with statistically significant improvement in uncontrolled hypertension management.

Comparative effectiveness of generic nifedipine versus Adalat long-acting nifedipine for hypertension treatment: A multi-institutional cohort study.

This retrospective multi‐institutional database analysis aimed to evaluate the blood‐pressure‐lowering efficacy and clinical outcomes of a generic versus brand‐name nifedipine for hypertension management. A total of 12 693 patients who were prescribed a generic or brand‐name nifedipine between January 1, 2011, and December 31, 2018, were identified from the Chang Gung Research Database of Chang Gung Memorial Hospitals, Taiwan. Among them, 2112 (21.4%) were prescribed generic nifedipine. After propensity score matching, both the generic and brand‐name groups consisted of 2102 patients. At a mean follow‐up of 3 years, the changes in office systolic (p for interaction = .791) and diastolic blood pressure (p for interaction = .689) did not differ significantly between the patients who received the generic and the brand‐name nifedipine. There was no significant difference between the two study groups regarding the composite of all‐cause mortality, acute myocardial infarction, stroke, coronary revascularization, or hospitalization for heart failure (hazard ratio 0.98, 95% confidence interval 0.85–1.13; p = .774). In conclusion, the generic nifedipine was comparable to its brand‐name counterpart regarding office blood pressure reduction and the composite cardiovascular outcome for the treatment of patients with hypertension.