24-hour Ambulatory Systolic Blood Pressure Research Articles

PREDICTION OF AMBULATORY HYPERTENSION WITH CLINIC AND HOME BLOOD PRESSURE RECORDINGS IN PATIENTS RECEIVING LONG-TERM PERITONEAL DIALYSIS

Objective: Contrary to patients on chronic hemodialysis, those receiving long-term peritoneal dialysis (PD) routinely measure and record their blood pressure (BP) at home. The accuracy of these routine home BP recordings relative to standardized clinic BP measurements in detecting hypertension confirmed by the “gold-standard” method of 24-hour ambulatory BP monitoring (ABPM) remains elusive. Design and method: A total of 56 consecutive patients on long-term PD underwent 24-hour ABPM with the oscillometric device Mobil-O-Graph (IEM, Germany). Triplicate clinic BP measurements under standardized conditions were obtained with a self-inflating automatic monitor (HEM 705 CP, Omron Healthcare). Morning home BP recordings routinely taken by the patients themselves the week prior to their study visit were also recorded and averaged. Results: In correlation analysis, both standardized clinic (r = 0.723, p < 0.001) and routine weekly-averaged morning home systolic BP (SBP) (r = 0.739, p < 0.001) exhibited strong positive associations with 24-hour ambulatory SBP. The area under the curve of receiver operating characteristic (ROC) curve for standardized clinic and routine home SBP to detect systolic ambulatory hypertension was 0.834 (95% CI: 0.725–0.939) and 0.832 (95% CI: 0.726–0.939), respectively. In Bland-Altman analysis, standardized clinic SBP overestimated 24-hour SBP by 6.62 mmHg with 95% limits of agreement ranging from −18.8 to 32.0 mmHg. Similarly, routine home SBP overestimated 24-hour SBP by 7.31 mmHg, again with wide 95% limits of agreement (−16.2 to 30.8 mmHg). Conclusions: This study suggests that home BP recordings routinely taken by patients on long-term PD do not offer additive value to that of standardized clinic BP in predicting ambulatory hypertension. Standardized protocols for home BP monitoring should be applied in order to improve hypertension management in the PD population.

Effect and safety of LCZ696 in the treatment of hypertension

LCZ696 has been introduced in patients with hypertension in several trials. Here, we performed a meta-analysis to evaluate the effect and safety of LCZ696 in hypertensive patients. PubMed, Embase, the Cochrane Library and ClinicalTrials.gov databases were searched to identify the available randomized controlled trials (RCTs) investigating the effect and safety of LCZ696 in hypertension patients. The last search date was October 31, 2018. Nine RCTs with 6765 subjects were finally included, in which 8 trials compared the effect and safety between LCZ696 and angiotensin receptor antagonists (ARBs). Evidences showed LCZ696, compared with ARBs, achieved a better blood pressure control rate (OR 1.24, 95% CI: 1.14-1.35), specifically, LCZ696 were better at reducing systolic blood pressure [WMD -4.11 mmHg, 95% CI: (-5.13, -3.08) mmHg], diastolic blood pressure [WMD -1.79 mmHg, 95% CI: (-2.22, -1.37) mmHg], mean 24-hour ambulatory systolic blood pressure [WMD -3.24 mmHg, 95% CI: (-4.48, -1.99) mmHg] and mean 24-hour ambulatory diastolic blood pressure [WMD -1.25 mmHg, 95% CI: (-1.81, -0.69) mmHg]. There was no difference in the events of adverse events (risk ratio [RR] 1.01, 95% CI: 0.39-1.09), serious adverse events (RR 0.80, 95% CI: 0.52-1.22) and discontinuation of treatment for any adverse events (RR 0.79, 95% CI: 0.56-1.11) between LCZ696 group and ARB/placebo group, except LCZ696 reduced the rate of headaches (RR 0.69, 95% CI: 0.48-0.99) while increased cough (RR 2.12, 95% CI: 1.11-4.04; P = .02; I = 25%). Our finding provides evidence that LCZ 696 was more effective than ARB on blood pressure control and was safe enough in patients with hypertension.

Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans

BackgroundThe prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established.MethodsIn this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months.ResultsThe mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, −3.14 mm Hg; 95% confidence interval [CI], −5.90 to −0.38; P=0.03; and −3.00 mm Hg; 95% CI, −5.8 to −0.20; P=0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was −0.14 mm Hg (95% CI, −2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups.ConclusionsThese findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.)

2019 Consensus Statement of the Taiwan Hypertension Society and the Taiwan Society of Cardiology on Renal Denervation for the Management of Arterial Hypertension.

Sympathetic overactivity, an essential mechanism of hypertension, in driving sustained hypertension derives mostly from its effects on renal function. Percutaneous renal denervation (RDN) is designed to disrupt renal afferent and efferent sympathetic nerves to achieve sustained blood pressure (BP) reduction. Since 2017 onward, all three proof-of-concept, sham-controlled RDN trials demonstrated that RDN achieved consistent and clinically meaningful BP reductions [approximately 10 mmHg in office systolic BP (SBP) and 6-9 mmHg in 24-hour SBP] compared to sham operation in patients with mild to moderate or uncontrolled hypertension. There were no serious adverse events. The registry data in Taiwan showed similar 24-hour BP reductions at 12 months following RDN. The Task Force considers RDN as a legitimate alternative antihypertensive strategy and recommends 1) RDN should be performed in the context of registry and clinical studies (Class I, Level C) and 2) RDN should not be performed routinely, without detailed evaluation of various causes of secondary hypertension and renal artery anatomy (Class III, Level C). RDN could be performed in patients who fulfill either of the following BP criteria: 1) office BP ≥ 150/90 mmHg and daytime ambulatory SBP ≥ 135 mmHg or diastolic BP (DBP) ≥ 85 mmHg, irrespective of use of antihypertensive agents (Class IIa, Level B), or 2) 24-hour ambulatory SBP ≥ 140 mmHg and DBP ≥ 80 mmHg, irrespective of use of antihypertensive agents (Class IIa, Level B), with eligible renal artery anatomy and estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. Five subgroups of hypertensive patients are deemed preferred candidates for RDN and dubbed "RDN i2": Resistant hypertension, patients with hypertension-mediated organ Damage, Non-adherent to antihypertensive medications, intolerant to antihypertensive medications, and patients with secondary (2ndary) causes being treated for ≥ 3 months but BP still uncontrolled. The Task Force recommends assessment of three aspects, dubbed "RAS" (R for renal, A for ambulatory, S for secondary), beforehand to ascertain whether RDN could be performed appropriately: 1) Renal artery anatomy eligibility assessed by computed tomography or magnetic resonance renal angiography if not contraindicated, 2) genuine uncontrolled BP confirmed by 24-hour Ambulatory BP monitoring, and 3) Secondary hypertension identified and properly treated. After the procedure, 24-hour ambulatory BP monitoring, together with the dose and dosing interval of all BP-lowering drugs, should be obtained 6 months following RDN. Computed tomography or magnetic resonance renal angiography should be obtained 12 months following RDN, given that renal artery stenosis might not be clinically evident.

Effect of a Walnut Diet on Office and 24-Hour Ambulatory Blood Pressure in Elderly Individuals

Nut consumption lowers blood cholesterol and is associated with reduced cardiovascular disease, but effects on blood pressure (BP) are inconsistent. We assessed the 2-year effects of a walnut diet versus a control diet on office BP and 24-hours ambulatory BP in free-living elders participating in the Walnuts and Healthy Aging study, a randomized trial testing the effects of walnuts at ≈15% energy on age-related disorders. In a prespecified analysis, we enrolled 305 participants, of whom 236 (75%) completed the study (65% women; age, 69 years; 60% with mild hypertension). Walnuts were well tolerated, and compliance was >98%. Mean baseline office BP was 128/79 mm Hg. Adjusted changes from baseline in mean office systolic BP were -4.61 mm Hg (95% CI, -7.43 to -1.79 mm Hg) in the walnut group and -0.59 mm Hg (-3.38 to 2.21 mm Hg) in controls ( P=0.051). Respective changes in mean systolic 24-hour ambulatory BP were -3.86 mm Hg (CI, -5.45 to -2.26 mm Hg) and -2.00 mm Hg (CI, -3.58 to -0.42 mm Hg; P=0.111). No changes in diastolic BP were observed. In participants in the upper tertile of baseline 24-hour ambulatory systolic BP (>125 mm Hg), mean 2-year systolic 24-hour BP was -8.5 mm Hg (CI, -12 to -5.0 mm Hg) in the walnut group and -2.5 mm Hg (CI, -6.3 to 1.3 mm Hg) in controls ( P=0.034). During the trial, participants in the walnut group required less uptitration of antihypertensive medication and had better overall BP regulation than controls. Walnut consumption reduces systolic BP in elderly subjects, particularly in those with mild hypertension. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01634841 .

Early morning-Best time window of hourly 24-hour ambulatory blood pressure in relation to hypertensive organ damage: The Japan Morning Surge-Home Blood Pressure study.

The correlations between organ damage and hourly ambulatory blood pressure (BP) have not been established. The patients were 1464 participants of the Japan Morning Surge-Home Blood Pressure (J-HOP) study participants who underwent ambulatory BP monitoring. The hourly systolic BP (SBP) at xo'clock was defined as the average of SBP values measured at times x-30minutes, x, and x+30minutes. The mean age was 64.8±11.6years. The percentage of male participants was 47.8%. The left ventricular mass index (LVMI) was significantly associated with SBP at 6o'clock (r=0.166, P<0.001). The carotid intima-media thickness was significantly associated with SBP at 5o'clock (r=0.196, P<0.001). After adjustment for age, sex, smoking, hyperlipidemia, diabetes mellitus, antihypertensive drug use, clinic SBP, and 24-hour ambulatory SBP, the correlations of the LVMI and hourly SBP at 6o'clock remained significant (beta coefficient=0.125, P<0.01). In conclusion, morning ambulatory systolic BP especially at 5 and 6o'clock was independently associated with organ damage.

Circulating Anthocyanin Metabolites Mediate Vascular Benefits of Blueberries: Insights From Randomized Controlled Trials, Metabolomics, and Nutrigenomics.

Potential health benefits of blueberries may be due to vascular effects of anthocyanins that predominantly circulate in blood as phenolic acid metabolites. We investigated which role blueberry anthocyanins and circulating metabolites play in mediating improvements in vascular function and explore potential mechanisms using metabolomics and nutrigenomics. Purified anthocyanins exerted a dose-dependent improvement of endothelial function in healthy humans, as measured by flow-mediated dilation. The effects were similar to those of wild blueberries containing similar amounts of anthocyanins, whereas control drinks containing fiber, minerals, or vitamins had no significant effect. Daily 1-month wild blueberry consumption increased flow-mediated dilation and lowered 24-hour ambulatory systolic blood pressure. Of the 63 anthocyanin plasma metabolites quantified, 14 and 21 correlated with acute and chronic flow-mediated dilation improvements, respectively. Injection of these metabolites improved flow-mediated dilation in mice. Daily wild blueberry consumption led to differential expression (>1.2-fold) of 608 genes and 3 microRNAs, with Mir-181c showing a 13-fold increase in peripheral blood mononuclear cells. Patterns of 13 metabolites were independent predictors of gene expression changes and pathway enrichment analysis revealed significantly modulated biological processes involved in cell adhesion, migration, immune response, and cell differentiation. Our results identify anthocyanin metabolites as major mediators of vascular bioactivities of blueberries and changes of cellular gene programs. Trial registration: NCT025208.

Safety and Efficacy of a New Renal Denervation Catheter in Hypertensive Patients in the Absent of Antihypertensive Medications: A Pilot Study.

Aim The aim of present study was to determine the safety and efficacy of a new renal artery denervation system for treatment of hypertensive patients. Methods Hypertensive patients with mean office systolic blood pressure ≥150mmHg and ≤180mmHg or an average of 24-hour ambulatory systolic blood pressure ≥145mmHg and ≤170mmHg after stopping hypertensive medications for 2 weeks or more were enrolled to undergo renal denervation (RDN) using a new RDN system. Changes in office blood pressure and mean 24-hour ambulatory blood pressure and safety were assessed after 6 months. Results Fifteen patients underwent RDN and followed up for 6 months. At the 6-month follow-up, office systolic blood pressure decreased 11.5±9.9mmHg (P<0.01) and office diastolic blood pressure decreased 6.9±4.8mmHg (P<0.01); mean 24-hour ambulatory systolic blood pressure decreased 7.5±7.7mmHg (P<0.05) and mean 24-hour diastolic blood pressure decreased 3.3±4.7mmHg (P>0.05) compared to baseline values. There were no serious RDN-related adverse events during follow-up. Conclusion Our results demonstrate that the new RDN system is safe and could significantly reduce blood pressure in hypertensive patients in the absence of antihypertensive medications. This trial is registered with ChiCTR1800017815.

Effect of liraglutide on ambulatory blood pressure in patients with hypertension and type 2 diabetes: A randomized, double-blind, placebo-controlled trial.

To assess the effect of liraglutide on 24-hour ambulatory blood pressure and heart rate in patients with hypertension (pre- and stage 1 hypertension) and inadequately controlled Type 2 diabetes (glycated haemoglobin 7%-10% [53-86 mmol/mol]). Eligible patients for this investigator-initiated, parallel-group, randomized, double-blind trial were on stable background antihyperglycaemic therapy excluding insulin, glucagon-like peptide-1 receptor agonists and dipeptidyl-peptidase-4 inhibitors. Participants were centrally randomized in a 1:1 ratio to daily liraglutide 0.6 mg, titrated to 1.2 mg after the first week, or placebo for 5 weeks. The primary outcome was change in 24-hour ambulatory systolic blood pressure (SBP), and secondary outcomes included change in ambulatory diastolic blood pressure (DBP) and heart rate. We also assessed renal sodium handling. Of 87 patients assessed for eligibility, 62 (66.1% men) with a mean age of 60.2 years were randomized to liraglutide (n = 31) or placebo (n = 31). All participants received background therapy with metformin, whilst 35.5% were treated concomitantly with sulphonylureas and 14.5% with pioglitazone. Compared with placebo, liraglutide reduced 24-hour SBP by -5.73 mm Hg (95% confidence interval [CI] -9.81 to -1.65) and had a neutral effect on 24-hour DBP (mean difference - 1.42 mm Hg; 95% CI -4.25 to 1.40), whilst increasing 24-hour heart rate by 6.16 beats/min (95% CI 3.25 to 9.07). Findings were consistent for daytime and night-time measurements. Liraglutide did not increase urine sodium excretion. Based on 24-hour ambulatory measurements, short-term treatment with liraglutide had a favourable effect on SBP whilst increasing heart rate.

Cardiovascular endpoints for obstructive sleep apnea with twelfth cranial nerve stimulation (CARDIOSA‐12): Rationale and methods

To determine the effect of therapeutic levels of hypoglossal nerve stimulation therapy (HGNS), compared to subtherapeutic levels of HGNS, on 24-hour ambulatory blood pressure, sympathetic activity, and vascular function. Double-blind, sham-controlled, randomized crossover trial of 10-week duration at a university medical center METHODS: The target enrollment is 60 randomly assigned subjects. Interventions are active versus sham (subtherapeutic) HGNS therapy. The primary outcome is 24-hour ambulatory systolic blood pressure. Secondary outcomes include 24-hour ambulatory diastolic blood pressure, nocturnal systolic and diastolic pressure, muscle sympathetic nerve activity, pre-ejection period, flow-mediated dilation, and pulse wave velocity. The Cardiovascular Endpoints for Obstructive Sleep Apnea With Twelfth Cranial Nerve Stimulation study is designed to examine obstructive sleep apnea and test the effects of HGNS on the cardiovascular system through a sham-controlled trial in patients with moderate-severe obstructive sleep apnea. 1 Laryngoscope, 2635-2643, 2018.

Relationships among clinic, home, and ambulatory blood pressures with small vessel disease of the brain and functional status in older people with hypertension

Subcortical small vessel disease, represented as white matter hyperintensity (WMH) on magnetic resonance images (MRI) is associated with functional decline in older people with hypertension. We evaluated the relationships of clinic and out-of-office blood pressures (BP) with WMH and functional status in older persons. Using cross-sectional data from 199 older study participants enrolled in the INFINITY trial, we analyzed the clinic, 24-hour ambulatory, and home BPs and their relationships with WMH burden and mobility and cognitive outcomes. Volume of WMH was associated with clinic and 24-hour ambulatory systolic BP but not home systolic BP. The mobility measure, supine-to-sit time, had a significant association with 24-hour systolic BP and pulse pressure but not with diastolic BP or values obtained by home BP. Cognitive measures of processing speed (Trails Making Test Part A and the Stroop Word Test) were significantly associated with 24-hour systolic BP, but not clinic and home BPs. These data demonstrate that ambulatory BP measurements in older people are more strongly associated with WMH and certain measures of functional status compared to home BP measurements. Hence, home BP may not be a useful substitute for ambulatory BP for assessing subcortical small vessel disease and its consequences. Further longitudinal analyses comparing clinic and various types of out-of-office BP measures with small vessel brain disease are needed. Clinicaltrials.gov identifier: NCT01650402.

Comparison of Effectiveness of Azilsartan Medoxomil and Olmesartan in Blacks Versus Whites With Systemic Hypertension

Two post hoc analyses in self-identified black and white patients with hypertension evaluated the angiotensin II receptor blocker azilsartan medoxomil (AZL-M) and the fixed-dose combination of AZL-M with chlorthalidone (AZL-M/CLD) versus the ARB olmesartan (OLM) and the OLM fixed-dose combination with hydrochlorothiazide (OLM/HCTZ). One analysis pooled 1,610 patients from two 6-week randomized controlled trials to compare once daily AZL-M 40 mg, AZL-M 80 mg, OLM 40 mg, and placebo. The second analysis included 1,020 patients from a 12-week randomized controlled trial to compare once daily AZL-M/CLD 40/25 mg, AZL-M/CLD 80/25 mg, and OLM/HCTZ 40/25 mg. Efficacy end points were 24-hour mean ambulatory and clinic systolic and diastolic blood pressure (SPB/DBP) and the percentage of patients achieving clinic SBP/DBP targets. Treatment with AZL-M 80 mg lowered mean clinic SBP by 12.5 mm Hg (p <0.01 vs OLM), treatment with AZL-M/CLD 40 mg/25 mg lowered mean ambulatory SBP by 31.0 mm Hg and mean clinic SBP by 39.3 mm Hg (both p <0.05 vs OLM/HCTZ), and treatment with AZL-M/CLD 80 mg/25 mg lowered mean ambulatory SBP by 34.4 mm Hg (p <0.01 vs OLM/HCTZ) and mean clinic SBP by 39.2 mm Hg (p <0.05 vs OLM/HCTZ). Target BP goals were achieved more frequently with AZL-M versus OLM and with AZL-M/CLD versus OLM/HCTZ. In conclusion, in both black and white patients, BP was lowered more effectively with AZL-M versus OLM and with AZL-M/CLD versus OLM/HCTZ. The AZL-M/CLD 40 mg/25 mg combination resulted in a statistically significant reduction in BP in both black and white patients.

LONG-TERM OUTCOME OF THE RANDOMIZED OSLO-RDN STUDY

Objective: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment resistant hypertension (TRH) shows variation among the few randomized studies. The duration of antihypertensive effect and long-term effect and safety of RDN requires further follow-up. We aimed to report the office, ambulatory blood pressure changes as well as long-term safety at 3 years follow-up in our Oslo-RDN study.Design and method: Patients with apparent TRH (n = 65) were referred specifically for RDN and those with secondary and spurious hypertension (n = 26) were excluded. TRH was defined as office systolic BP > 140 mmHg despite maximally tolerated doses of at least 3 antihypertensive drugs including a diuretic. Furthermore, ambulatory daytime systolic BP > 135 mmHg following witnessed intake of antihypertensive drugs was required. This procedure revealed that 20 patients had normalized BP, indicating poor adherence, and these patients were excluded. Patients with true TRH were randomized and underwent RDN with Symplicity catheter (n = 9) versus adjusted drug treatment (n = 10). Patients came for follow-up 3–4 years after baseline. Results: 24-hour ambulatory systolic and diastolic BPs in the drug adjustment group changed from 151 ± 13/84 ± 7 mmHg at baseline to 132 ± 15/77 ± 6 mmHg at 3-years, and in the RDN group from 149 ± 9/89 ± 7 mmHg at baseline to 137 ± 13/81 ± 10 mmHg at 3-years follow-up. Office, daytime and nighttime ambulatory BPs changed in parallel to the 24-hour ambulatory BPs. The absolute differences in systolic or diastolic BPs between the groups were consistent with earlier follow up points with a tendency toward a smaller difference between the groups. The difference in systolic BP at long-term follow up was not significant (p = 0.34). There were no significant changes in renal arteries assessed by MRI or CT scans at long-term follow-up. No deterioration of renal function was observed. Conclusions: The results at the three-year follow-up are consistent with earlier time points, with a tendency toward a smaller difference in BPs between the TRH and RDN groups. Our data support that RDN is a safe procedure on long-term follow-up and this allows further research to identify characteristics of patients who might respond to RDN.

Association of 24-Hour Blood Pressure With Urinary Sodium Excretion in Healthy Adults.

While the positive relationship between urinary sodium excretion and blood pressure (BP) is well established for middle-aged to elderly individuals using office BP, data are limited for younger individuals and ambulatory BP measurements. Our analysis included 2,899 individuals aged 18 to 90 years from 2 population-based studies (GAPP, Swiss Kidney Project on Genes in Hypertension [SKIPOGH]). Participants with prevalent cardiovascular disease, diabetes, or on BP-lowering treatment were excluded. In SKIPOGH, 24-hour urinary sodium excretion was used as a measure of sodium intake, while in GAPP it was calculated from fasting morning urinary samples using the Kawasaki formula. Multivariable linear regression models were used to assess the relationships of 24-hour urinary salt excretion with office and ambulatory BP measurements. Mean age, ambulatory BP, sodium excretion, and estimated glomerular filtration rate in GAPP and SKIPOGH were 35 and 44 years, 123/78 and 118/77 mm Hg, 4.2 and 3.3 g/d, and 110 and 99 ml/min/1.73 m2, respectively. A weak linear association was observed between 24-hour ambulatory systolic BP and urinary sodium excretion (β (95% confidence interval [CI]) per 1 g increase in sodium excretion (0.33 % (0.09; 0.57); P = 0.008). No significant relationships were observed for 24-hour ambulatory diastolic BP (β (95% CI) (0.13 % (-0.15; 0.40) P = 0.37). When repeating the analyses in different age groups, all BP indices appeared to have stronger relationships in the older age groups (>40 years). In these large cohorts of healthy adults, urinary sodium excretion was only weakly associated with systolic 24-hour ambulatory BP.

Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized, double-blind, 8-week study.

A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200mg (97/103mg) to continued olmesartan 20mg in reducing ambulatory systolic BP after 8-week treatment in patients with mild to moderate essential hypertension uncontrolled with olmesartan 20mg alone. A total of 376 patients were randomized to receive either sacubitril/valsartan (n=188) or olmesartan (n=188). Superior reductions in 24-hour mean ambulatory systolic BP were observed in the sacubitril/valsartan group vs the olmesartan group (-4.3mmHg vs -1.1mmHg, P<.001). Reductions in 24-hour mean ambulatory diastolic BP and pulse pressure and office systolic BP and diastolic BP were significantly greater with sacubitril/valsartan vs olmesartan (P<.014). A greater proportion of patients achieved BP control with sacubitril/valsartan vs olmesartan. The overall incidence of adverse events was comparable between the groups. Compared with continued olmesartan, sacubitril/valsartan was more effective and generally safe in patients with hypertension uncontrolled with olmesartan 20mg.

Frailty, Disability, and Ambulatory Blood Pressure in Older Adults

Background and objectiveFrailty and disability are associated with cardiovascular risk factors, including hypertension, in older people; however, little is known about their association with ambulatory blood pressure (BP). Thus, we assessed the relationship of frailty and disability with ambulatory BP in older adults. Design, setting, and participantsCross-sectional study of 1047 community-living individuals aged ≥60 years in Spain. MeasurementsBP was determined with validated devices under standardized conditions during 24 hours. Frailty was defined as having 3 or more of the following criteria: weight loss, low grip strength, low energy, slow gait speed, and low physical activity. Disability was assessed with the Lawton-Brodýs questionnaire on instrumental activities of daily living. Associations with systolic BP (SBP) and dipping (nocturnal SBP decline) were modeled and adjusted for sociodemographic variables, body mass index, lifestyles, antihypertensive drug treatment, comorbidities, 24-hour heart rate, and conventional or ambulatory SBP as appropriate. ResultsParticipants' mean age was 71.7 years (50.8% men); 6% were frail and 8.1% had disability. Compared with nonfrail participants, those with frailty had 3.5 mm Hg lower daytime SBP (P = .001), 3.3% less SBP dipping (P = .003), and 3.6 mmHg higher nighttime SBP (P = .016). Compared with participants who are not disabled, those who are disabled had 2.5 mmHg lower daytime SBP (P = .002), 2.5% less SBP dipping (P = .003), and 2.7 mmHg higher nighttime SBP (P = .011). ConclusionsIn community-dwelling older adults, frailty and disability were independently associated with lower diurnal SBP, blunted nocturnal decline of SBP, and higher nocturnal SBP. These findings may help explain the higher mortality associated with low clinic SBP in frail older subjects observed in epidemiologic studies.

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018.

Relationship between subendocardial viability ratio and hemoglobin in patients with chronic kidney disease.

Pulse wave analysis (PWA) uses the technique of applanation tonometry to obtain a peripheral pulse pressure waveform from which central hemodynamic information is derived. Using PWA, subendocardial viability ratio (SEVR) can be measured. SEVR represents a noninvasive measure of myocardial perfusion. It is related to the work of the heart, the oxygen consumption, and the energy supply of the heart. Anemia is a common complication of chronic kidney disease (CKD). A complex relationship exists between CKD, cardiovascular disease (CVD), and anemia. The aim of our study was to assess the relationship between SEVR and hemoglobin in non-dialysis CKD patients. We examined the associations between PWA hemodynamic parameters, 24-hour ambulatory blood pressure (BP) measurements, and laboratory variables including hemoglobin, cardiac biomarkers troponin I, NT-proBNP, and hs-CRP in a cohort of 91 nondialysis CKD patients. PWA was assessed by radial applanation tonometry (SphygmoCor, Atcor, Sydney, Australia). The patients were divided into two groups according to the median value of hemoglobin. Mean age of included patients was 60.2 years, 67% were men, 44% were smokers, 25.3% had diabetes. A significant correlation between hemoglobin and SEVR was found (r=0.26; p=0.012). With multivariate regression analysis, SEVR as dependent variable turned out to be statistically significantly associated with hemoglobin (β=0.344, p=0.013) and with troponin I (β=-0.217, p=0.037). Patients in the group with lower hemoglobin had statistically-significantly higher serum creatinine, cystatin C, NT-proBNP, and 24-hour ambulatory systolic BP and lower e-GFR, SEVR, and office diastolic BP. Results of our study show that SEVR is independently associated with hemoglobin in nondialysis CKD patients. CKD patients with lower hemoglobin have lower SEVR. .

Longitudinal Changes in Excess Pressure Independently Predict Declining Renal Function Among Healthy Individuals-A Pilot Study.

Aortic reservoir function independently predicts end-organ damage in cross-sectional analyses. However, longitudinal associations are more important regarding causation, but this has never been examined at rest or in response to light-moderate intensity exercise. The aim of this study was to determine the association between the change in aortic reservoir characteristics, in particular excess pressure integral (Pexcess) at rest and in response to exercise and the change in kidney function among healthy individuals followed over time. Aortic reservoir function (Pexcess and reservoir pressure), aortic stiffness, brachial and central blood pressure (BP), and renal function (estimated glomerular filtration rate [eGFR]) were recorded among 33 healthy individuals (57 ± 9 years; 55% male) at baseline and after an average 3.0 ± 0.3 years. Over the follow up period, there was a significant increase in resting brachial BP, central BP, Pexcess, and aortic stiffness (P < 0.05 all). The change over time in resting Pexcess (but not aortic stiffness) was significantly related to the change in eGFR (r = -0.38, P = 0.038) and remained independent of age at follow up, change in 24-hour ambulatory systolic BP and body mass index (β = -0.0300, P = 0.043). There was no association between the change in aortic pulse wave velocity and the change eGFR (P = 0.46) nor were there any associations with exercising hemodynamics. Pexcess is independently associated with a decline in renal function among healthy people followed over 3 years. These novel findings indicate the need to determine the underlying physiological determinants of aortic reservoir function.

Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.

Renal denervation has been shown to reduce blood pressure in patients with uncontrolled hypertension, but less is known about its impact on quality of life. This analysis evaluated 12-month blood pressure and quality of life outcomes in 934 patients from the Global SYMPLICITY Registry who completed the EuroQoL five-dimensions three-level questionnaire (EQ-5D-3L). At baseline, 32% of patients reported anxiety/depression and 48% reported pain/discomfort. At 12months (n=496), office and 24-hour ambulatory systolic blood pressure were reduced by 13.9±26.6 and 7.7±19.3mmHg, respectively, and 8% (P<.001) more patients reported no problems in anxiety/depression. Furthermore, numerically more patients reported no problems in pain/discomfort (4%, P=.08). Perceived health-related quality of life (visual analog scale) improved from baseline to 12months (68±18 vs 73±17, P<.001), and the improvement was largest among patients with severe anxiety/depression at baseline (50±24 vs 64±22, P=.005 [n=32]). In this analysis, renal denervation was associated with a significant improvement in health-related quality of life, particularly anxiety/depression.