Reduction In Ambulatory Systolic Blood Pressure Research Articles

Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis.

Renal denervation is a recognized adjunct therapy for hypertension with clinically significant blood pressure (BP)-lowering effects. Long-term follow-up data are critical to ascertain durability of the effect and safety. Aside from the 36-month follow-up data available from randomized control trials, recent cohort analyses extended follow-up out to 10 years. We sought to analyze study-level data and quantify the ambulatory BP reduction of renal denervation across contemporary randomized sham-controlled trials and available long-term follow-up data up to 10 years from observational studies. A systematic review was performed with data from 4 observational studies with follow-up out to 10 years and 2 randomized controlled trials meeting search and inclusion criteria with follow-up data out to 36 months. Study-level data were extracted and compared statistically. In 2 contemporary randomized controlled trials with 36-month follow-up, an average sham-adjusted ambulatory systolic BP reduction of -12.7±4.5 mm Hg from baseline was observed (P=0.05). Likewise, a -14.8±3.4 mm Hg ambulatory systolic BP reduction was found across observational studies with a mean long-term follow-up of 7.7±2.8 years (range, 3.5-9.4 years; P=0.0051). The observed reduction in estimated glomerular filtration rate across the long-term follow-up was in line with the predicted age-related decline. Antihypertensive drug burden was similar at baseline and follow-up. Renal denervation is associated with a significant and clinically meaningful reduction in ambulatory systolic BP in both contemporary randomized sham-controlled trials up to 36 months and observational cohort studies up to 10 years without adverse consequences on renal function.

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

Renal denervation: A safe, effective, and long-lasting blood pressure-lowering therapy.

In The Journal of Clinical Hypertension, Tino Naduvathumuriyil and colleagues report the results of their single-center registry on the effects of renal denervation (RDN) in resistant hypertension patients. They report that a total of 50 resistant hypertension patients underwent RDN using three different systems. The data from their registry showed that office blood pressure (BP) reductions following RDN were sustained throughout the follow-up periods of up to 3 years. Mean office BP was reduced from 170.6/93.4 mm Hg at baseline to 144.2/84.6 mm Hg at 36 months. Mean changes in office systolic and diastolic BP after 36 months were −26.4 and −8.8 mm Hg (95% CI: −34.6 to −18.2 and −13.5 to −4.2 mm Hg, n = 28), respectively. Patients at the very highest BP level—greater than 180 mm Hg systolic at baseline—appeared to benefit the most from the procedure at three years. Based on office BP, 100% and 82% of patients with grade 3 hypertension were responders at 24 and 36 months, respectively. Additionally, the proportion of patients with an office systolic BP ≥ 180 mm Hg dropped from 30% at baseline to 7.4% at 3 years. Although plasma creatinine increased from 90.6 μmol/L (95% CI: 82.1-99.0 μmol/L) at baseline to 102.1 μmol/L (95% CI: 95.8-108.3 μmol/L) at 36 months (P = .007), no long-term safety concerns were observed following the RDN procedure. The study is an important evidence around RDN as a safe, effective, and long-lasting BP-lowering therapy. The Global SYMPLICITY Registry is the largest study documenting the long-term safety and effectiveness of the Medtronic renal denervation systems in a real-world setting in patients with uncontrolled hypertension.1 This single-center study, as a useful supplement to the Global SYMPLICITY Registry, reconfirmed the long-term efficacy of lowering blood pressure in RDN. The recently published randomized, sham-controlled SPYRAL HTN-OFF MED (Efficacy of catheter-based renal denervation in the absence of antihypertensive medications [SPYRAL HTN-OFF MED Pivotal]: a multicentre, randomised, sham-controlled trial)2 and (Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications [SPYRAL HTN-OFF MED]: a randomised, sham-controlled, proof-of-concept trial),3 SPYRAL HTN-ON MED (Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial),4 and RADIANCE SOLO (Endovascular ultrasound renal denervation to treat hypertension [RADIANCE-HTN SOLO]: a multicentre, international, single-blind, randomised, sham-controlled trial)5 trials documented significant and consistent reductions in both office and ambulatory BP in patients with and without concomitant antihypertensive medication, while results are short term. Although the sample size is relatively small, the encouraging findings of this single-center registry support to the clinical application of RDN, a legitimate antihypertensive strategy, for uncontrolled hypertension. This single-center registry showed a substantial reduction in office BP after RDN using 3 different catheter-based radiofrequency ablation systems: the Symplicity RDN system from Medtronic, the EnligHTN RDN system from St. Jude Medical/Abbott, and the Vessix RDN system from Boston Scientific. This first comparison of 3 different radiofrequency ablation RDN systems reveals novel findings. Although the average BP reductions were modest and the number of patients was small, head-to-head comparison showed an advantage for Vessix RDN system perhaps because of the more complete renal nerve ablation. At present, there are a variety of RDN devices with different technologies, but different devices should have different effects. Both radiofrequency and ultrasound endovascular RDN systems have proven clinical efficacy for the treatment of hypertension. The Radiosound-HTN comparative trial has shown that RDN using endovascular ultrasound afforded superior reduction in ambulatory systolic BP in comparison with radiofrequency ablation system.6 Questions that remain open and require further evidence in future studies relate to the long-term safety and efficacy of both the radiofrequency ablation devices and that of other devices with different technologies in larger cohorts. A head-to-head comparison may be useful to determine the potential superiority of all the devices. Selection of suitable patients for RDN therapy is the key to the success of RDN. The ultimate litmus test is to identify responders and nonresponders to RDN therapy. The problem remains unresolved. In this small sample study, patients with grade 3 or higher hypertension had a better response, while the BP response was variable. Although more patients demonstrated BP reduction with RDN than with the sham procedure, there were changes seen in either direction for both groups in SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, and RADIANCE SOLO trials. In any case, following the positive SPYRAL HTN-OFF MED Pivotal data, these new data provide additional evidence on the safety and efficacy of RDN to help manage uncontrolled hypertension, with study patients experiencing meaningful blood pressure reductions out to several years. None disclaimers.

Acute antihypertensive effect of self-selected exercise intensity in older women with hypertension: a crossover trial.

PurposeAcute reduction in blood pressure (BP) following an exercise session is evidenced in controlled settings with formal supervision in hypertensive older populations. This study investigated the effect of a self-selected exercise (SSE)-intensity session on ambulatory BP in hypertensive older women in a “real-world” setting.MethodsTwenty inactive older women with hypertension (64.9±4.5 years) were included in this randomized, controlled, crossover trial. After baseline assessments, participants performed 30 minutes of an SSE-intensity session on an outdoor track and a control session, separated by 7-10 days. Heart rate (HR), rating of perceived exertion (RPE), and affective response were assessed. Ambulatory BP was monitored for 20 hours following both sessions. Paired t-tests and generalized estimation were used for data analysis.ResultsParticipants exercised at 5.1±1.1 km/h, spent ~90% of the exercise time at moderate–vigorous intensity (≥40% of heart rate reserve). SSE-intensity session was reported as light (RPE 11.0±1.5) and pleasant (affect 3.4±1.2). SSE-intensity session elicited reductions in systolic BP in the first 6 hours postexercise (6.0 mmHg, CI 2.7–9.3 mmHg; P<0.001). Average systolic BP in the 20-hour (−3.4 mmHg, CI −5.9 to −0.9 mmHg; P=0.010) and awake (−4.0 mmHg, CI −6.4 to −1.6 mmHg; P=0.003) periods were lower following SSE-intensity session compared to control session. No differences were observed in average systolic BP during asleep period and diastolic BP during the 20-hour awake and asleep periods between the SSE-intensity session and control session (P>0.05).ConclusionAn SSE-intensity session elicited a reduction in ambulatory systolic BP in inactive older women with hypertension during awake and 20-hour periods. Also, the SSE-intensity session was reported as light and pleasant.

Effects of alcohol restriction on ambulatory blood pressure, heart rate, and heart rate variability in Japanese men

We investigated the effects of alcohol restriction on ambulatory blood pressure (BP), heart rate, and heart rate variability in 33 Japanese male volunteers (37 ± 1 years, mean ± SE), who were all habitual drinkers. Subjects were told either to keep their usual drinking habits for 3 weeks (usual alcohol period), or to reduce alcohol intake by at least half of their usual drinking amount (reduced alcohol period). The ambulatory BP, heart rate, and electrocardiographic R-R intervals were measured during a 24-h period with a portable recorder on the last day of each period. A power spectral analysis of R-R intervals was performed to obtain the low-frequency (LF) and high-frequency (HF) components. The percentage of differences between adjacent normal R-R intervals >50 msec (pNN50) was also calculated. The amount of ethanol intake was significantly reduced from 70 ± 5 mL/day in the usual alcohol period to 19 ± 3 mL/day in the reduced alcohol period ( P < .0001). The daytime systolic BP was significantly lower in the reduced alcohol period than in the usual alcohol period by 4 ± 1 mm Hg ( P < .05). The daytime and nighttime heart rate was significantly lower in the reduced alcohol period than in the usual alcohol ( P < .001 for each). The pNN50 and the HF component were significantly higher in the reduced alcohol period than in the usual alcohol period ( P < .0001 for each). The LF/HF ratio was significantly lower in the reduced period than in the usual period ( P < .01). These results demonstrate that 3-week alcohol restriction produced reductions in ambulatory systolic BP, heart rate, and the index of sympathovagal balance, and augmentations of parasympathetic indices of heart rate variability in Japanese male drinkers.

Sex difference in response of blood pressure to calcium antagonism in the treatment of moderate-to-severe hypertension

The pressor response to examination in the clinic setting is called the 'white coat effect' (WCE). This response may be a confounder when investigators use clinic blood pressure as a measure of response to antihypertensive therapy. ;To study the effect of the pressor response by evaluating the sex-specific effect of treatment with calcium antagonism on blood pressure measured in the clinic and by ambulatory blood pressure monitoring (ABPM). Untreated hypertensive subjects (n=39) with seated clinic diastolic blood pressures (DBP) > or = 100 and < or = 130mmHg were studied. Same-day clinic systolic blood pressure (SBP) and ambulatory SBP were obtained after 1 week of placebo, and after 1 month of treatment with either nifedipine or verapamil in a randomized, blinded, parallel trial. With placebo, women s average SBP was 18+/-;4mmHg lower than clinic SBP. By contrast, men s average SBP with placebo was 4+/-15mmHg lower than clinic SBP. There was a significantly greater reduction in clinic SBP for women than there was for men after 1 month of treatment (by 33+/-13 versus 18+/-18mmHg, P<0.005). However, reduction in ambulatory SBP after 1 month was the same for both sexes (20+/-11 versus 19+/-12mmHg). In this study of moderate-to-severe hypertensives, the large WCE measured for women, which markedly diminished with treatment, accounts for the observed sex difference in response of clinic SBP to calcium antagonism. By contrast, with ABPM there was an equivalent response to treatment for both sexes. Use of ABPM could be a valuable means of eliminating the WCE as a confounder in clinical research.

Effects of cessation of caffeinated-coffee consumption on ambulatory and resting blood pressure in men

Coffee consumption has been weakly linked to high blood pressure (BP). The hypothesis that cessation of caffeinated-coffee consumption lowers ambulatory BP was tested in men in a randomized trial. One hundred eighty-six middle-aged, normotensive, male, habitual caffeinated-coffee consumers were recruited. Of these subjects, 150 had sufficiently complete, ambulatory BP measurements for analysis. After 2 months of standard caffeinated-coffee consumption, subjects were randomized to consume an equal amount of the same standard caffeinated coffee or a standard decaffeinated coffee, or to discontinue coffee consumption for 2 months. Diet composition, body weight and exercise did not change. Resting BP and heart rate were not different between the groups before and after intervention. In comparison with the continued caffeinated-coffeegroup (control), the decaffeinated-coffee group revealed significant reductions in mean ambulatory systolic BP during the morning (−4.0 ± 11 mm Hg; p =0.014), afternoon (−5.3 ± 10 mm Hg; p = 0.001) and evening (−3.2 ± 10 mm Hg; p = 0.003) hours, reductions in mean ambulatory diastolic BP during the afternoon (−1.8 ± 10 mm Hg; p =0.063) and evening (−1.8 ± 10 mm Hg; p = 0.059) hours and no change in ambulatory heart rate. The group randomized to no coffee revealed significant reductions in ambulatory systolic BP during the morning (−4.1 ± 9 mm Hg; p = 0.007), afternoon (−3.3 ± 10 mm Hg; p =0.023) and evening (−2.2 ± 11 mm Hg; p = 0.015) hours, significant reductions in ambulatory diastolic BP during the afternoon (−2.6 ± 6 mm Hg; p = 0.006) and evening (−2.1 ± 6 mm Hg; p = 0.016) hours, and no significant change in ambulatory heart rate. This suggests that cessation of caffeinated coffee results in significant reductions in ambulatory systolic and diastolic BP in normotensive men, which are not apparent from resting BP measurements.