Renal denervation improves exercise blood pressure: insights from a randomized, sham-controlled trial

Fengler, Karl; Heinemann, Diana; Okon, Thomas; Röhnert, Karoline; Stiermaier, Thomas; Röder, M. von; Besler, Christian; Müller, Ulrike; Höllriegel, Robert; Schuler, Gerhard; Desch, Steffen; Lurz, Philipp

doi:10.1007/s00392-015-0955-8

Cited by 13 publications

(5 citation statements)

References 36 publications

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“…The 16 studies including 681 patients reported different HR types involving office HR, 24 h-HR, daytime HR, and nighttime HR. The mean HR of baseline was between 60 and 80 bpm, and the SBP at baseline was higher than 140 mmHg except the study by Fengler et al (19). The extracted results are shown in Table 3.…”

Section: Included Literature Characteristics and Resultsmentioning

confidence: 95%

“…However, the heterogeneity did not significantly decrease in other subgroups. Furthermore, we performed the Galbraith radial plot to identify the inter-study heterogeneity and found that three studies by Mahfound et al ( 16 ), Fengler et al ( 19 ), and Lurz et al ( 28 ) may be the sources of the heterogeneity ( Figure 5 ).…”

Section: Resultsmentioning

confidence: 99%

“…A total of 70 articles were assessed by browsing full-texts, and 54 records were excluded (48 did not report the related data; 4 were not the target study population; and 2 were duplicate articles). Finally, 16 eligible clinical trials were included in the meta-analysis (10,11,(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) (Figure 1).…”

Section: Literature Search Resultsmentioning

confidence: 99%

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Effect of Renal Denervation for the Management of Heart Rate in Patients With Hypertension: A Systematic Review and Meta-Analysis

Xiong

et al. 2022

Front. Cardiovasc. Med.

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Objective:The effect of renal denervation (RDN) on heart rate (HR) in patients with hypertension had been investigated in many studies, but the results were inconsistent. This meta-analysis was performed to evaluate the efficacy of RDN on HR control.Methods:Databases, such as PubMed, EMBASE, Cochrane, and ClinicalTrials.gov, were searched until September 2021. Randomized controlled trials (RCTs) or non-RCTs of RDN in hypertensive patients with outcome indicators, such as HR, were selected. Weighted mean difference (WMD) was calculated for evaluating the changes in HR from baseline using fixed-effects or random-effects models. The Spearman's correlation coefficients were used to identify the relationship between the changes of HR and systolic blood pressure (SBP).Results:In the current meta-analysis, 681 subjects from 16 individual studies were included. This study showed that RDN could reduce office HR in patients with hypertension [WMD = −1.93 (95% CI: −3.00 to −0.85, p < 0.001)]. In addition, 24-h HR and daytime HR were decreased after RDN [WMD = −1.73 (95% CI: −3.51 to −0.31, p = 0.017) and −2.67 (95% CI: −5.02 to −0.32, p = 0.026) respectively], but nighttime HR was not significantly influenced by RDN (WMD = −2.08, 95% CI: −4.57 to 0.42, p = 0.103). We found that the reduction of HR was highly related to the decrease of SBP (r = 0.658, p < 0.05).Conclusion:Renal denervation could reduce office, 24-h, and daytime HR, but does not affect nighttime HR. And the effect is highly associated with blood pressure (BP) control.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO, identifier: CRD42021283065.

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Section: Included Literature Characteristics and Resultsmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 99%

Section: Literature Search Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Effect of Renal Denervation for the Management of Heart Rate in Patients With Hypertension: A Systematic Review and Meta-Analysis

Xiong

et al. 2022

Front. Cardiovasc. Med.

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“…From this sample, a total of 97 end points were identified, for which paired data meeting full inclusion criteria were available from at least 1 blinded and at least 1 unblinded trial (Table 1). These data were obtained from 72 blinded and 55 unblinded trials, incorporating 111 500 patient data points: 51 688 in blinded trials and 59 812 in unblinded trials.…”

Section: Resultsmentioning

confidence: 98%

Placebo Control and Blinding in Randomized Trials of Procedural Interventions

Rajkumar,

Thomas,

Foley

et al. 2024

JAMA Surg

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ImportanceUnlike medications, procedural interventions are rarely trialed against placebo prior to becoming accepted in clinical practice. When placebo-controlled trials are eventually conducted, procedural interventions may be less effective than previously believed.ObjectiveTo investigate the importance of including a placebo arm in trials of surgical and interventional procedures by comparing effect sizes from trials of the same procedure that do and do not include a placebo arm.Data SourcesSearches of MEDLINE and Embase identified all placebo-controlled trials for procedural interventions in any specialty of medicine and surgery from inception to March 31, 2019. A secondary search identified randomized clinical trials assessing the same intervention, condition, and end point but without a placebo arm for paired comparison.Study SelectionPlacebo-controlled trials of anatomically site-specific procedures requiring skin incision or endoscopic techniques were eligible for inclusion; these were then matched to trials without placebo control that fell within prespecified limits of heterogeneity.Data Extraction and SynthesisRandom-effects meta-regression, with placebo and blinding as a fixed effect and intervention and end point grouping as random effects, was used to calculate the impact of placebo control for each end point. Data were analyzed from March 2019 to March 2020.Main Outcomes and MeasuresEnd points were examined in prespecified subgroups: patient-reported or health care professional–assessed outcomes, quality of life, pain, blood pressure, exercise-related outcomes, recurrent bleeding, and all-cause mortality.ResultsNinety-seven end points were matched from 72 blinded, placebo-controlled trials (hereafter, blinded) and 55 unblinded trials without placebo control (hereafter, unblinded), including 111 500 individual patient end points. Unblinded trials had larger standardized effect sizes than blinded trials for exercise-related outcomes (standardized mean difference [SMD], 0.59; 95% CI, 0.29 to 0.89; P &lt; .001) and quality-of-life (SMD, 0.32; 95% CI, 0.11 to 0.53; P = .003) and health care professional–assessed end points (SMD, 0.40; 95% CI, 0.18 to 0.61; P &lt; .001). The placebo effect accounted for 88.1%, 55.2%, and 61.3% of the observed unblinded effect size for these end points, respectively. There was no significant difference between unblinded and blinded trials for patient-reported end points (SMD, 0.31; 95% CI, −0.02 to 0.64; P = .07), blood pressure (SMD, 0.26; 95% CI, −0.10 to 0.62; P = .15), all-cause mortality (odds ratio [OR], 0.23; 95% CI, −0.26 to 0.72; P = .36), pain (SMD, 0.03; 95% CI, −0.52 to 0.57; P = .91), or recurrent bleeding events (OR, −0.12; 95% CI, −1.11 to 0.88; P = .88).Conclusions and RelevanceThe magnitude of the placebo effect found in this systematic review and meta-regression was dependent on the end point. Placebo control in trials of procedural interventions had the greatest impact on exercise-related, quality-of-life, and health care professional–assessed end points. Randomized clinical trials of procedural interventions may consider placebo control accordingly.

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“…Recent evidence indicated that hyperactivation of the renal sympathetic nerves could lead to decreased water and sodium reabsorption as well as renal blood flow and stimulate the renin-angiotensin-aldosterone system, leading to elevated BP (Henegar et al, 2015;Fengler et al, 2017;Chen et al, 2017). During the past decade, a number of studies have extensively evaluated the regulation of BP by reducing renal sympathetic activity through invasive and noninvasive treatments (Fengler et al, 2016;Mahfoud et al, 2017). Among them, percutaneous RDN is the most widely studied.…”

Section: Discussionmentioning

confidence: 99%

Effects of different ablation points of renal denervation on the efficacy of resistant hypertension

Zhang

Xiao

et al. 2020

PeerJ

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Objective To explore the blood pressure response to different ablation points of renal denervation (RDN) in patients with resistant hypertension Methods A total of 42 cases with resistant hypertension treated by RDN in our center from 2013 to 2015 were retrospectively analyzed. The patients were divided into two groups according to the different ablation points of RDN: the standard treatment group (spiral ablation from near to proximal, with less than 8 points per artery) and the intensive treatment group (from near to far by spiral ablation, with at least 8 points per artery), with 21 patients in each group. The ablation parameters, including points, impedance, actual wattage, and actual temperature, were recorded intraoperatively. Renal angiography was performed again after RDN. Ambulatory blood pressure (ABP) images were taken for all patients at the baseline and 6 months after operation. Results The mean 24-h blood pressure of the standard treatment group was lower than that of the baseline (24-h systolic blood pressure decreased by 7.4 ± 10.6 mmHg and 24-h diastolic blood pressure decreased by 4.6 ± 6.1 mmHg), and the mean 24-h blood pressure decreased significantly from baseline to 6 months in the intensive treatment group (24–h systolic blood pressure decreased by 27.4 ± 11.4 mmHg, P < 0.0001; 24–h diastolic blood pressure decreased by 10.9 ± 9.6 mmHg, P = 0.005). There was a positive correlation between the decrease of systolic/diastolic 24-hour mean and the number of ablation points used in the procedure. The mean value of systolic and diastolic blood pressure was positively correlated with ablation points at 24-hour (R2 = 0.777 and 0.633 respectively, P < 0.01). There were no adverse events in either group after the operation and during the follow-up. Conclusions RDN could significantly reduce BP in patients with resistant hypertension. Our study showed that the antihypertensive effect appeared to be positively correlated with the number of ablation points.

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Renal denervation improves exercise blood pressure: insights from a randomized, sham-controlled trial

Abstract: Exercise systolic BP values in patients with mild therapy-resistant hypertension are reduced after RSD as compared to a sham-procedure.

Cited by 13 publications

References 36 publications

Effect of Renal Denervation for the Management of Heart Rate in Patients With Hypertension: A Systematic Review and Meta-Analysis

Effect of Renal Denervation for the Management of Heart Rate in Patients With Hypertension: A Systematic Review and Meta-Analysis

Placebo Control and Blinding in Randomized Trials of Procedural Interventions

Effects of different ablation points of renal denervation on the efficacy of resistant hypertension

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