24-hour Ambulatory Systolic Blood Pressure Research Articles

PATIENTS WITH RESISTANT HYPERTENSION AND ATRIAL FIBRILLATION ARE THE BEST RESPONDERS FOR RENAL DENERVATION

Objective: The search for the ideal candidate for renal denervation (RDN) is one of the priority treatments of patients with resistant hypertention (RH). Our objective was to identify the predictors of the efficiency of renal denervation. Design and method: The study included 112 patients with RH. The average age of patients was 53 [19; 69] years. Twenty-four (21.4%) patients had atrial fibrillation (AF). Four (16.7%) patients had chronic AF, 8 (33.3%) patients had persistent AF, and 12 (50%) – paroxysmal AF. All patients underwent RDN. Procedure was performed by an experienced electrophysiologist at the renal arteries using specialized electrode Symplicity Flex (Medtronic): ablation power = 8 - 10 W at 55°C, 4 – 10 points for each renal artery (including brunches), 2 minutes per point. Office BP and 24-hour ambulatory BP, 24-hour ECG monitoring, arrhythmia chronocard diaries were measured before, at 6 and 12 months of follow-up. A logistic regression analysis included the following parameters: gender, age, body mass index, office and 24-hour ambulatory systolic blood pressure (SBP), diabetes mellitus and the AF presence. Results: baseline office SBP and DBP in patients with RH were 185.4 ± 29.19 and 109.96 ± 17.95 respectively. Office BP decreased by 29.8 /14.1 mmHg at 12 month after RDN (p < 0.001). 24-hour ambulatory SBP decreased from 161.3 ± 25.9 mm Hg to 148.1 ± 21.3 mm Hg at 12 months after the intervention, DBP from 94.3 ± 16.4 mm Hg to 87.2 ± 15.9 mmHg (p < 0,001). It was found that all patients (100%) with RH and AF were responders to renal denervation. This response is defined as a reduction of office SBP of less than 10 mmHg following RDN. Whereas 17.2% of non-AF group patients were non-responders. The number of symptomatic AF paroxysms significantly decreased from 9 [2; 11] to 2 [1; 3] one year after RDN (p = 0.001). Conclusions: Patients with RH and AF are among the best candidates for RDN. It may help to improve the selection of patients with arterial hypertension for the RDN.

Prioritised endpoints for device-based hypertension trials: the win ratio methodology.

Multiple endpoints with varying clinical relevance are available to establish the efficacy of device-based treatments. Given the variance among blood pressure measures and medication changes in hypertension trials, we performed a win ratio analysis of outcomes in a sham-controlled, randomised trial of renal denervation (RDN) in patients with uncontrolled hypertension despite commonly prescribed antihypertensive medications. We propose a novel prioritised endpoint framework for determining the treatment benefit of RDN compared with sham control. We analysed the SPYRAL HTN-ON MED pilot study data using a prioritised hierarchical endpoint comprised of 24-hour mean ambulatory systolic blood pressure (SBP), office SBP, and medication burden. A generalised pairwise comparisons methodology (win ratio) was extended to examine this endpoint. Clinically relevant thresholds of 5 and 10 mmHg were used for comparisons of ambulatory and office SBP, respectively, and therefore to define treatment "winners" and "losers". For a total number of 1,596 unmatched pairs, the RDN subject was the winner in 1,050 pairs, the RDN subject was the loser in 378 pairs, and 168 pairs were tied. The win ratio in favour of RDN was 2.78 (95% confidence interval [CI]: 1.58 to 5.48; p<0.001) and corresponding net benefit statistic was 0.42 (95% CI: 0.20 to 0.63). Sensitivity analyses performed with differing blood pressure thresholds and according to drug adherence testing demonstrated consistent results. The win ratio method addresses prior limitations by enabling inclusion of more patient-oriented results while prioritising those endpoints considered most clinically important. Applying these methods to the SPYRAL HTN-ON MED pilot study (ClinicalTrials.gov Identifier: NCT02439775), RDN was determined to be superior regarding a hierarchical endpoint and a "winner" compared with sham control patients.

Is the newest angiotensin-receptor blocker azilsartan medoxomil more efficacious in lowering blood pressure than the older ones? A systematic review and network meta-analysis.

Angiotensin‐receptor blockers are often considered insufficiently efficacious in reducing blood pressure. However, newer angiotensin‐receptor blockers may be more effective than the older ones. A network meta‐analysis was performed to compare the efficacy of various angiotensin‐receptor blockers in reducing office and ambulatory blood pressure in hypertensive patients. Relevant literature was searched from English and Chinese databases for randomized controlled trials involving angiotensin‐receptor blockers in hypertension. Efficacy variables included systolic and diastolic blood pressure either in the office or on ambulatory blood pressure monitoring. Absolute blood pressure reductions at 6‐12 weeks of treatment and their credible intervals were reported. A total of 34 publications provided adequate data for analysis (n = 14 859). In 28 studies on office systolic blood pressure (n = 12 731), against the common comparator valsartan 80 mg, the differences in systolic blood pressure were in favor of azilsartan medoxomil (20‐80 mg), irbesartan (300 mg), olmesartan (20‐40 mg), telmisartan (80 mg), and valsartan (160‐320 mg), but not candesartan (8‐16 mg), losartan (50‐100 mg), irbesartan (150 mg), olmesartan (10 mg), and telmisartan (40 mg). The ranking plot shows that azilsartan medoxomil 80 mg had a possibility of 99% being the best in the class. Similar results were observed for office diastolic blood pressure and from 13 studies for 24‐hour ambulatory systolic and diastolic blood pressure. In conclusion, angiotensin‐receptor blockers had different blood pressure lowering efficacy. The newest angiotensin‐receptor blocker azilsartan medoxomil at the dose of 80 mg seemed to be most efficacious in reducing both systolic and diastolic blood pressure in the office and on ambulatory measurement.

Ambulatory blood pressure profile and stroke recurrence

ObjectivesTo establish a new ambulatory blood pressure (ABP) parameter (24-hour ABP profile) and evaluated its performance on stroke outcome in ischaemic stroke (IS) or transient ischaemic attack (TIA) patients.MethodsThe prospective...

An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX™ in Patients with Uncontrolled Hypertension on Standard Medical Therapy.

Background and ObjectivesDENEX™ is a novel renal sympathetic denervation (RDN) system that is equipped with 3 electrodes that deliver radiofrequency energy to the renal nerves along renal arteries. The purpose of this study was to evaluate the safety and efficacy of RDN with DENEX™ in resistant hypertension.MethodsThis was an open-label, single-arm, multicenter, first-in-man pilot study. Between November 2016 and May 2018, a total of 16 patients were enrolled at 4 centers in South Korea. The inclusion criteria were systolic blood pressure (SBP) ≥150 mmHg and use of 3 or more antihypertensive medications, including diuretics. The primary objective was the safety outcome of RDN with the DENEX™ system. The secondary objective was efficacy outcome based on changes of office, and 24-hour ambulatory SBP from baseline to 3 months. The patients underwent abdominal computed tomography (CT) or duplex ultrasonogram before and 6 months after RDN.ResultsNo major adverse events occurred after RDN for 6 month of follow-up period. There was no vascular complication either by CT or duplex ultrasonogram. The office SBP was significantly reduced from 164.6±11.6 mmHg at baseline to 142.0±20.4 mmHg (−24.4±24.4 mmHg, p=0.003) at 3 months. The ambulatory SBP was reduced from 151.44±12.85 mmHg at baseline to 140.0±16.5 mmHg (−13.1±18.9 mmHg, p=0.056) at 3 months.ConclusionRDN with the DENEX™ system showed a favorable safety profile in resistant hypertension. A significant reduction in office SBP and a borderline reduction in ambulatory SBP were observed.Trial RegistrationClinicalTrials.gov Identifier: NCT04248530

Abstract 15350: The State of Renal Sympathetic Denervation for the Management of Patients With Hypertension: A Systematic Review &amp; Meta-analysis

Introduction: Sympathetic nervous system plays a central role in the development and persistence of essential hypertension. In recent years Renal Sympathetic Denervation (RSD) has emerged as a promising option for the treatment of patients with hypertension Hypothesis: Despite the availability of multiple anti-hypertensive medications, data from the national health and nutritional survey shows that lifelong polypharmacy is failing as a therapeutic strategy due to lack of awareness and compliance with medications. The significant cost in terms of morbidity and mortality associated with uncontrolled hypertension calls for nonpharmacologic approaches for management. Methods: We conducted a literature search of PubMed, EMBASE, Cochrane library and Clinicaltrials.gov from inception through May 20, 2020. Outcomes of interest were change in 24-hour ambulatory systolic (ASBP) or diastolic blood pressure (ADBP) and change in office systolic (OSBP) or diastolic blood pressure (ODBP). We pooled data from randomized controlled trials (RCTS) comparing RSD to sham procedures in the management of hypertension using the random effect model. Results: A total of 1,363 patients from 8 studies were included in the current meta-analysis. The mean age of the included patients was 56 ± 2.6 years, 29 % were women and the median duration of maximum follow up was 6-month (range 3-12 month). There was more reduction favoring RSD in ASBP (Weighted mean difference (WMD) -3.55; 95%CI -4.91 - -2.19, p&lt;0.001, I 2 =0%), ADBP (WMD -1.87; 95%CI -3.07 - -0.66, p=0.002, I 2 =43%) , OSBP (WMD -5.5; 95%CI -7.59 - -3.40, p&lt;0.001, I 2 =7%) and ODBP (WMD -3.20; 95%CI -4.47 - -1.94, p&lt;0.001, I 2 =14%). Conclusions: The use of RSD for the management of hypertension resulted in effective reduction in the ambulatory and office blood pressure compared to sham procedure. Adequately powered RCTs of RSD are needed to confirm safety, reproducibility and assess the impact on clinical outcomes.

The state of renal sympathetic denervation for the management of patients with hypertension: A systematic review and meta-analysis.

Sympathetic nervous system plays a central role in the development and persistence of essential hypertension. In recent years renal sympathetic denervation (RSD) has emerged as a promising option for the treatment of patients with hypertension. We conducted a literature search of PubMed, EMBASE, Cochrane library and Clinicaltrials.gov from inception through April 20, 2020. Outcomes of interest were change in 24-hour ambulatory systolic (ASBP) or diastolic blood pressure (ADBP) and change in office systolic (OSBP) or diastolic blood pressure (ODBP). We pooled data from randomized controlled trials (RCTS) comparing RSD to sham procedures in the management of hypertension using the random effect model. A total of 1,363 patients from eight studies were included in the current meta-analysis. The mean age of the included patients was 56 ± 2.6 years, 29% were women and the median duration of maximum follow up was 6-month (range 3-12 month). There was more reduction favoring RSD in ASBP (Weighted mean difference [WMD] -3.55; 95% CI -4.91 - -2.19, p < .001, I2 = 0%), ADBP (WMD -1.87; 95% CI -3.07 - -0.66, p = .002, I2 = 43%), OSBP (WMD -5.5; 95% CI -7.59 - -3.40, p < .001, I2 = 7%) and ODBP (WMD -3.20; 95% CI -4.47 - -1.94, p < .001, I2 = 14%). The use of RSD for the management of hypertension resulted in effective reduction in the ambulatory and office blood pressure compared to sham procedure. Adequately powered RCTs of RSD are needed to confirm safety, reproducibility and assess the impact on clinical outcomes.

Pharmacotherapy for hyperuricaemia in hypertensive patients.

This is the second update of this systematic review.High blood pressure represents a major public health problem. Worldwide, approximately one-fourth of the adult population has hypertension. Epidemiological and experimental studies suggest a link between hyperuricaemia and hypertension. Hyperuricaemia affects 25% to 40% of those with untreated hypertension; a much lower prevalence has been reported in those with normotension or in the general population. However, whether lowering serum uric acid (UA) might lower blood pressure (BP), is an unanswered question. To determine whether UA-lowering agents reduce BP in people with primary hypertension or prehypertension, compared with placebo. The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to May2020: the Cochrane Hypertension Specialised Register, CENTRAL 2018, Issue 12, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also searched LILACS (1982 to May2020),and contacted authors of relevant papers regarding further published and unpublished work. The searches had no language or date restrictions. To be included in this updated review, the studies had to meet the following criteria: 1) randomised or quasi-randomised, with a group assigned to receive a UA-lowering agent and another group assigned to receive placebo; 2) double-blind, single-blind, or open-label; 3) parallel or cross-over trial design; 4) cross-over trials had to have a washout period of at least two weeks; 5) minimum treatment duration of four weeks; 6) participants had to have a diagnosis of essential hypertension or prehypertension plus hyperuricaemia (serum UA greater than 6 mg/dL in women, 7 mg/dL in men, and 5.5 mg/dL in children or adolescents); 7) outcome measures included change in 24-hour ambulatory systolic or diastolic BP, or both; or clinic-measured systolic or diastolic BP, or both. The two review authors independently collected the data using a data extraction form, and resolved any disagreements via discussion. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We assessed the certainty of the evidence using the GRADE approach. In this review update, we screened 722 records, selected 26 full-text reports for evaluation. We identified no ongoing studies and did not add any new studies. We included three randomised controlled trials (RCTs), enrolling 211 people with hypertension or prehypertension, plus hyperuricaemia. Low-certaintyevidence from three RCTs found inconclusive results between those who received UA-lowering drugs and placebo, in 24-hour ambulatory systolic (MD -6.2 mmHg, 95% CI -12.8 to 0.5) or diastolic BP (-3.9 mmHg, 95% CI -9.2 to 1.4). Low-certaintyevidence from two RCTs found that UA-lowering drugs reduced clinic-measured systolic BP (-8.43 mmHg, 95% CI -15.24 to -1.62) but results for clinic-measured diastolic BP were inconclusive (-6.45 mmHg, 95% CI -13.60 to 0.70). High-certaintyevidence from three RCTs found that serum UA levels were reduced by 3.1 mg/dL (95% CI 2.4 to 3.8) in the participants that received UA-lowering drugs. Low-certaintyevidence from three RCTs found inconclusive results regarding the occurrence of adverse events between those who received UA-lowering drugs and placebo (RR 1.86, 95% CI 0.43 to 8.10). In this updated Cochrane Review, the current RCT data are insufficient to know whether UA-lowering therapy lowers BP. More studies are needed.

SO035EFFECT OF DIETARY SALT REDUCTION ON BLOOD PRESSURE IN KIDNEY TRANSPLANT PATIENTS: A RANDOMISED CONTROLLED TRIAL

Abstract Background and Aims Cardiovascular morbidity and mortality are increased in kidney transplant patients. High blood pressure (BP) contributes significantly to this risk and is associated with shortened allograft survival. Dietary salt reduction is widely recommended as a strategy to lower BP in the general population and in chronic kidney disease. Due to a lack of evidence there is currently no consensus on dietary salt restriction in kidney transplant patients. The primary aim of the study was to examine the impact of reduced dietary salt intake on BP in kidney transplant patients. Method Sixty stable kidney transplant patients, ≥ 6-months post-transplantation, with BP ≥120/80 mmHg, and sodium intake ≥80 mmol/24hrs, were randomised in this parallel-designed study to receive either a regular-salt diet (target 150 mmol/24hr) or a low-salt diet (target 80 mmol/24hr) for 8-weeks. The primary outcome measure was systolic and diastolic BP. Secondary outcome measures included 24-hour ambulatory BP (ABP) and proteinuria. Dietary salt intake was assessed by 48-hour urinary sodium excretion. Results At baseline, patients (72% men) were 56±11 years with estimated glomerular filtration rate (eGFR) 53±18 mL/min/1.73m2. Mean urinary sodium was 128±42 mmol/24hr, mean systolic BP was 132±12 mmHg, and mean diastolic BP was 77±10 mmHg. At the end of the intervention period sodium excretion was significantly lower in the low-salt group compared with the regular-salt group (90±37 vs. 132±51 mmol/24hr; adjusted mean difference, -36 [95% CI, -59 to -14] mmol/24hr; P=0.002). We found no difference in systolic BP (adjusted mean difference, -2 [95% CI, -12 to 9] mmHg; P=0.750), diastolic BP (adjusted mean difference, 0 [95% CI, -4 to 4] mmHg; P=0.887), 24-hour systolic ABP (adjusted mean difference, -3 [95% CI, -9 to 2] mmHg; P=0.213) or 24-hour diastolic ABP (adjusted mean difference, -2 [95% CI, -5 to 1] mmHg; P=0.267). There was no significant effect on proteinuria or eGFR. Conclusion In this study baseline urinary sodium was lower than expected and baseline BP was well controlled. Reducing dietary salt by 2g/day did not have a significant effect on office blood pressure readings.

P0158RENAL DENERVATION VERSUS SPIRONOLACTONE IN THE TREATMENT OF RESISTANT HYPERTENSION: A META-ANALYSIS

Abstract Background and Aims Resistant hypertension (RH) is defined as blood pressure that remains above guideline-directed goal despite the concurrent use of at least three antihypertensive agents of different classes, one of which is a diuretic. Treatment of RH is focused on the addition of fourth-line therapy. Several studies revealed impressive blood pressure reductions when spironolactone was added to the therapeutic regimen. In the recent years, there has been a growing perception that controlling blood pressure in resistant hypertension is beyond the reach of existing drug therapies, leading to the emergence of device-based therapies, such as renal denervation. Our aim is to do a systematic review of randomized controlled trials that compares the use of Spironolactone and Renal Denervation in patients with RH. Method A comprehensive literature search from the PubMed, Embase, Cochrane Library, and Ovid was performed with the following search terms: Resistant Hypertension, Spironolactone, Renal Denervation. The search was limited to randomized-controlled trials that compared Spironolactone to Renal Denervation in patients with Resistant Hypertension. Three prospective clinical trials were selected and analyzed using Cochrane Revman v5.3. Primary outcome were mean changes in 24-hour Ambulatory Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). Secondary outcomes include mean changes in Office SBP and DBP. Safety was assessed by changes in eGFR and potassium levels. Results Two trials comprising 130 patients were selected - 63 patients treated with RDN and 67 patients with Spironolactone. Pooled analysis of the 2 trials for 24H SBP and DBP showed an adjusted standardized mean difference of 0.55 mmHg (CI -0.72, 1.82; P = 0.39) and 0.32 mmHg (CI -0.72, 1.35; P = 0.55) with significant heterogeneity. No significant differences were also noted in terms of decline in eGFR (p = 0.07) and changes in serum potassium (p = 0.29) from baseline to 6 months. Conclusion Based on our results, RD appears to be safe and effective treatment for RH. However, additional larger studies should be done including a cost-benefit analysis to explore that possibility of RD as treatment alternative for those intolerant of spironolactone or as a possible 5th line of treatment for those already taking spironolactone.

Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study

Rationale & ObjectiveGroup-based care provides an opportunity to increase patient access to providers without increasing physician time and is effective in the management of chronic diseases in the general population. This model of care has not been investigated in chronic kidney disease (CKD).Study DesignRandomized controlled trial in adults (n = 50); observational study in adolescents (n = 10).Setting & ParticipantsAdults and adolescents with CKD and hypertension in the Bronx, NY.InterventionGroup-based care (monthly sessions over 6 months) versus usual care in adults. All adolescents received group-based care and were analyzed separately.OutcomesParticipant attendance and satisfaction with group-based care were used to evaluate intervention feasibility. The primary clinical outcome was change in mean 24-hour ambulatory blood pressure. Secondary outcomes included physical activity, medication adherence, quality of life, and sodium intake as assessed by 24-hour urinary sodium excretion and food frequency questionnaires.ResultsAmong adults randomly assigned to group-based care, attendance was high (77% of participants attended ≥3 sessions) and most reported higher satisfaction. Mean 24-hour ambulatory systolic blood pressure decreased by −4.2 (95% CI, −13.3 to 5.8) mm Hg in group-based care patients compared with usual care at 6 months but this was not statistically significant. Similarly, we did not detect significant differences in health-related behaviors (such as medication adherence, sodium intake, and physical activity) or quality-of-life measures between the 2 groups. Among the adolescents, attendance was very poor; self-reported satisfaction, although high, did not change from baseline compared with the 6-month follow-up.LimitationsSmall study size, missing data.ConclusionsGroup-based care is feasible and acceptable among adults with hypertension and CKD. However, a larger trial is needed to determine the effect on blood pressure and health-related behaviors. Patient participation may limit the effectiveness of group-based care models in adolescents.FundingNational Institutes of Health R34 DK102174.Trial registrationhttps://clinicaltrials.gov/show/NCT02467894.

Diagnostic Accuracy of Unattended Automated Office Blood Pressure Measurement in Screening for Hypertension in Kenya.

Despite increasing adoption of unattended automated office blood pressure (uAOBP) measurement for determining clinic blood pressure (BP), its diagnostic performance in screening for hypertension in low-income settings has not been determined. We determined the validity of uAOBP in screening for hypertension, using 24-hour ambulatory BP monitoring as the reference standard. We studied a random population sample of 982 Kenyan adults; mean age, 42 years; 60% women; 2% with diabetes mellitus; none taking antihypertensive medications. We calculated sensitivity using 3 different screen positivity cutoffs (≥130/80, ≥135/85, and ≥140/90 mm Hg) and other measures of validity/agreement. Mean 24-hour ambulatory BP monitoring systolic BP was similar to mean uAOBP systolic BP (mean difference, 0.6 mm Hg; 95% CI, -0.6 to 1.9), but the 95% limits of agreement were wide (-39 to 40 mm Hg). Overall discriminatory accuracy of uAOBP was the same (area under receiver operating characteristic curves, 0.66-0.68; 95% CI range, 0.64-0.71) irrespective of uAOBP cutoffs used. Sensitivity of uAOBP displayed an inverse association (P<0.001) with the cutoff selected, progressively decreasing from 67% (95% CI, 62-72) when using a cutoff of ≥130/80 mm Hg to 55% (95% CI, 49-60) at ≥135/85 mm Hg to 44% (95% CI, 39-49) at ≥140/90 mm Hg. Diagnostic performance was significantly better (P<0.001) in overweight and obese individuals (body mass index, >25 kg/m2). No differences in results were present in other subanalyses. uAOBP misclassifies significant proportions of individuals undergoing screening for hypertension in Kenya. Additional studies on how to improve screening strategies in this setting are needed.

P4566Comparison of standard renal denervation procedure versus novel distal and branch vessel ablation with brachial arterial access

Abstract Objectives We assessed a novel approach to percutaneous renal denervation for uncontrolled hypertension consisting of ablation beyond the proximal main renal artery (Y-pattern), including the primary branches, and compared it to the standard procedure applied only within the main vessel. We also assessed the safety and practicality of a brachial access approach. Methods and results Renal denervation was performed on 119 consecutive patients (60±13 years). In 68 of the patients, femoral arterial vascular approach was used and in 51 brachial. In 80 patients treated with the standard ablation, 12.0±3.0 total ablations (both sides) were applied while 20.4±3.9 total ablations were delivered for the group of 39 patients with Y-pattern denervation (P&lt;0.001). Technically successful renal denervation was achieved in all patients. Office blood-pressure levels at baseline were 170±17/93±10 mm Hg for the standard group and 169±13/96±9 mm Hg for the Y-pattern group. No major adverse events occurred during the procedure or in the postprocedural in-hospital period. Renal denervation was associated with significant decreases in both office and ambulatory systolic and diastolic blood pressure in both groups. The reduction in 24-hour mean ambulatory systolic blood pressure at 6 months was significantly greater (P=0.002) for the Y-Pattern group (−22.1±15.4 mm Hg) compared to the Standard group (−11.8±16.2 mm Hg). Changes in diastolic office and ambulatory pressure were also significantly greater at 6 months in the Y-pattern ablation group. Indices of blood pressure variability improved in both groups. Between group comparison of blood pressure and other parameters at follow up Standard Y-Pattern P (Standard vs Y) Change in Office Diastolic Blood Pressure (mmHg) 1 Month −8.0±13.2* −9.8±8.5* 0.49 3 Months −6.3±6.9* −6.4±9.0* 0.96 6 Months −5.0±9.0* −9.9±10.8* 0.01 Change in Ambulatory Diastolic Pressure (mmHg) 24-Hour −5.2±8.4* −6.2±10.0* 0.61 Daytime −3.2±9.4* −5.6±10.0* 0.24 Night Time −7.6±8.4* −6.5±11.5* 0.56 Antihypertensive Medication Classes 4.9±1.1* 5.3±0.8* 0.07 otal Number of Lesions† 12.0±3.0 20.4±3.9 &lt;0.001 Conclusion Renal denervation using a Y-pattern ablation strategy combined with a greater number of lesions is safe and resulted in significant greater decreases in mean 24-hour ambulatory systolic and diastolic blood pressure compared to the conventional

Effect of Catheter-Based Renal Denervation on Uncontrolled Hypertension: A Systematic Review and Meta-analysis

ObjectiveTo assess the efficacy and safety of catheter-based renal denervation (RDN) for the treatment of uncontrolled hypertension by conducting a systematic review and a meta-analysis. MethodsThe Medline, Cochrane Library, and Embase databases were searched for clinical studies between January 1, 2009, and July 16, 2018. Studies that evaluated the effect of RDN on uncontrolled hypertension were identified. The primary endpoints were changes in 24-hour ambulatory systolic blood pressure (BP) and office systolic BP. The secondary endpoints included changes in 24-hour ambulatory diastolic BP, office diastolic BP, and major adverse events. ResultsAfter a literature search and detailed evaluation, 12 randomized controlled trials with a total of 1539 individuals were included in the quantitative analysis. Pooled analyses indicated that RDN was associated with a significantly greater reduction of 24-hour systolic BP (mean difference [MD], −4.02 mm Hg; 95% CI, −5.49 to −2.56; P<.001) and office systolic BP (MD, −8.93 mm Hg; 95% CI, −14.03 to −3.83; P<.001) than controls. Similarly, RDN significantly reduced 24-hour diastolic BP (MD, −2.05 mm Hg; 95% CI, −3.05 to −1.05; P<.001) and office diastolic BP (MD, −4.49 mm Hg; 95% CI, −6.46 to −2.52; P<.001). RDN was not associated with an increased risk of major adverse events (relative risk, 1.06; 95% CI, 0.72 to 1.57; P=.76). ConclusionsCatheter-based RDN was associated with a significant BP-lowering benefit without increasing major adverse events.

A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure.

In this randomized, double-blind, placebo-controlled, multicentre, parallel, 8-week study, the efficacy of a daily dose of 1200 mg of protein hydrolysate from Coldwater Shrimp (Pandalus borealis) on ambulatory and office blood pressure was investigated in 144 free-living adults with mild to moderate hypertension. The primary outcomes of the study were daytime ambulatory systolic blood pressure and office blood pressure. During the 8-week intervention period and in the intention-to-treat analysis (n=144), there were significant reductions in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group in daytime ambulatory systolic blood pressure at 4 weeks (p=0.014) and at 8 weeks (p=0.002), and in office systolic blood pressure at 2 weeks (p=0.031) and 4 weeks (p=0.010), with a trend toward significance at 8 weeks (p=0.087). By 8 weeks, significant and favourable improvements in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group were also observed for several secondary outcomes, including 24-hour ambulatory systolic and diastolic blood pressure, daytime ambulatory diastolic blood pressure, and daytime and 24-hour ambulatory mean arterial pressure. Also by Week 8, there was a statistically significant difference between groups in the distribution of subjects across National Institutes of Health-defined blood pressure categories (i.e., Normotensive, Prehypertensive, Stage 1 hypertension, and Stage 2 hypertension), with a more favourable distribution in the shrimp-derived protein hydrolysate group than in the placebo group (p=0.006). Based on exploratory analyses conducted only in participants in the shrimp-derived protein hydrolysate group, angiotensin II levels were significantly reduced relative to baseline. This study is registered at ClinicalTrials.gov NCT01974570.

CAROTID VERSUS BRACHIAL BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS

Objective: To compare carotid and brachial office blood pressure (BP) in terms of their association with 24-hour ambulatory BP and preclinical organ damage in children and adolescents. Design and method: Apparently healthy children and adolescents (age 6–18 yeas) referred for elevated BP were subjected to (i) measurements of office brachial BP measurement (Microlife WatchBP Home N; duplicate measurements), carotid BP and carotid-femoral pulse wave velocity (Complior Analyse device; duplicate measurements), (ii) 24-hour ABP monitoring (Microlife WatchBP O3), (iii) carotid intima-media thickness (cIMT) measurement (high resolution B-mode ultrasonography) at the level of common carotid and bulb bilaterally using automated software, and (iv) echocardiographic determination of left ventricular mass index (LVMI). Results: 64 individuals were included (mean age 12.9 ± 3.2 years, 37 males, BMI 24.5 ± 5.1 kg/m2, 11 with ambulatory hypertension [BP >=95th percentile or >=130/80 mmHg]). Carotid office systolic BP (SBP) was lower than brachial office SBP (120.1 ± 16.7 vs. 125.5 ± 15.1 mmHg, p < 0.01). The brachial minus carotid SBP difference (amplification) did not differ in males vs. females (4.9 ± 6.3 and 5.9 ± 6.2 mmHg respectively, p = NS) or in hypertensives vs. normotensives (7.8 ± 4.4 and 4.8 ± 6.4 mmHg, p = NS) and was not associated with age (r = −0.05) or height (r = −0.13). Carotid and brachial office SBP were correlated to 24-hour ambulatory SBP (r = 0.75 and 0.83 respectively, both p < 0.05) and with each other (r = 0.93). 24-hour ambulatory, carotid and brachial office SBP were associated with all indices of preclinical organ damage (LVMI: r = 0.33, 0.22 and 0.28; cIMT: 0.47, 0.36 and 0.38; PWV: 0.55, 0.50 and 0.58 respectively; p = NS for comparisons of coefficients). Conclusions: These preliminary results suggest that in children and adolescents central BP assessed at the carotid artery with the Complior method is not superior to brachial office or ambulatory BP in terms of their association with preclinical organ damage.

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.