Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry

Vogel, Britta; Kirchberger, Michael C.; Zeier, Martin; Stoll, Felicitas; Meder, Benjamin; Saure, Daniel; Andrassy, Martin; Mueller, Oliver J; Hardt, Stefan; Schwenger, Vedat; Strothmeyer, Anna; Katus, Hugo A.; Blessing, Erwin

doi:10.1007/s00392-013-0627-5

Cited by 62 publications

(34 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…10,11 This effect occurs whenever a variable has inherent biological variability, and patients are selected on the basis of recording a high-value. Statistically, it is known as regression to the mean.…”

Section: Regression To the Meanmentioning

confidence: 99%

Magnitude of Blood Pressure Reduction in the Placebo Arms of Modern Hypertension Trials

et al. 2015

View full text Add to dashboard Cite

Early phase studies of novel interventions for hypertension, such as renal sympathetic denervation, are sometimes single-armed (uncontrolled). We explored the wisdom of this by quantifying the blood pressure fall in the placebo arms of contemporary trials of hypertension. We searched Medline up to June 2014 and identified blinded, randomized trials of hypertension therapy in which the control arm received placebo medication or a sham (placebo) procedure. For nonresistant hypertension, we have identified all such trials of drugs licensed by the US Food and Drug Administration since 2000 (5 drugs). This US Food and Drug Administration–related restriction was not applied to resistant hypertension trials. This produced 7451 patients, who were allocated to a blinded control from 52 trials of nonresistant hypertension and 694 patients from 8 trials of resistant hypertension (3 drugs and 2 interventions). Systolic blood pressure fell by 5.92 mm Hg (95% confidence interval, 5.14–6.71; P <0.0001) in the nonresistant cohort and by 8.76 mm Hg (95% confidence interval, 4.83–12.70; P <0.0001) in the resistant cohort. Using metaregression, the falls were larger in trials that did not use ambulatory blood pressure monitoring as an inclusion criterion ( z =2.84; P =0.0045), in those with higher baseline blood pressures ( z =−0.3; P =0.0001), and in those where the patients were prescribed a continuous background of antihypertensives ( z =−2.72; P =0.0065). The nontrivial magnitude of these apparent blood pressure reductions with perfectly ineffective intervention (placebo) illustrates that efficacy explorations of novel therapies for hypertension, once safety is established, should be performed with a randomized, appropriately controlled, and blinded design.

show abstract

Section: Regression To the Meanmentioning

confidence: 99%

Magnitude of Blood Pressure Reduction in the Placebo Arms of Modern Hypertension Trials

et al. 2015

View full text Add to dashboard Cite

show abstract

“…The persistence of high blood pressure (BP) in patients with resistant HT is partially regulated by the renal sympathetic nervous system (SNS) [2][3][4][5][6]. Therefore, renal sympathetic denervation (RSD) has been developed as an interventional treatment option for patients with uncontrolled HT when optimal medical treatment fails [7][8][9][10][11][12][13][14][15][16][17]. The randomized, blinded HTN-3 trial failed to meet its primary efficacy endpoint as the study did not show a significant reduction of systolic blood pressure (SBP) in patients with resistant hypertension 6 months after RSD compared with sham controls [18].…”

Section: Introductionmentioning

confidence: 99%

Neuropeptide Y as an indicator of successful alterations in sympathetic nervous activity after renal sympathetic denervation

et al. 2015

View full text Add to dashboard Cite

show abstract

“…In real-world setting, inclusion of patients and also technical performance in the centers can be different when compared with investigators performing the procedure in randomized, controlled trials. To investigate the effect in real life, registries such as the ongoing Global Symplicity Registry (GSR) with ≥5000 patients planned to be included, 127 as well as smaller single-center registries 128 are important to provide data on safety and efficacy in clinical practice conditions. For indications beyond hypertension, where significant BP reduction or other signs, symptoms or markers are not regarded as appropriate surrogates for outcomes, clinical end point studies adequately powered for safety and efficacy are urgently needed.…”

Section: Discussionmentioning

confidence: 99%

Renal Denervation for the Treatment of Cardiovascular High Risk-Hypertension or Beyond?

Böhm

Linz

Ukena

et al. 2014

Circulation Research

View full text Add to dashboard Cite

Hypertension imposes a major burden of morbidity and mortality and is associated with sympathetic nervous system overactivity. Renal sympathetic denervation has been shown to reduce office blood pressure, ambulatory blood pressure, and sympathetic activity in patients with resistant hypertension. Therefore, the procedure has attracted a lot of attention. Beyond blood pressure, renal denervation has been shown to improve glucose tolerance, microalbuminuria, and arrhythmias in several experimental models and, in admittedly, often uncontrolled clinical studies. It has been demonstrated to reduce myocardial hypertrophy in a blood pressure–independent and blood pressure–dependent way. The first studies on heart failure with preserved and reduced ejection fraction are ongoing. Renal sympathetic denervation holds promise for future indications in hypertension and related comorbidities and consequences, such as metabolic disease, renal failure, and heart failure. Published data in a placebo-control blinded study, however, are needed. The aim of this review is to provide a critical and comprehensive overview of heretofore generated data on renal denervation in experimental models, in human hypertension, and on early developments in new indications, which should indicate the way to powered and performed, controlled clinical studies appropriately.

show abstract

Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry

Abstract: RDN with the Symplicity™ system is safe and effective in patients with treatment-resistant hypertension also in a real-world setting.

Cited by 62 publications

References 26 publications

Magnitude of Blood Pressure Reduction in the Placebo Arms of Modern Hypertension Trials

Magnitude of Blood Pressure Reduction in the Placebo Arms of Modern Hypertension Trials

Neuropeptide Y as an indicator of successful alterations in sympathetic nervous activity after renal sympathetic denervation

Renal Denervation for the Treatment of Cardiovascular High Risk-Hypertension or Beyond?

Contact Info

Product

Resources

About