Renal 3 diet
Table S1 in the Supplementary Appendix shows the procedural characteristics for the two groups. 14 The blinding index ranges from 0 (all patients correctly guessed their study-group assignments) to 1 (all patients did not know their study-group assignments), with values greater than 0. (2016) Blood Pressure Control Provides Less Cardiovascular Protection in Adults With Than Without Apparent Treatment-Resistant Hypertension. Fishbein, Peng-Sheng Chen. e1. (2016) Future prospects for renal artery denervation. A limitation of this trial is that medication adherence could not be confirmed. Stevenson, Sana M. Swanton, E. Reilly, Christopher J. Adobe Flash Player is required to view this feature. CrossRef 39 Tanja Dudenbostel, David A. Patel, Carl Hayward, Sebastian Ewen, Felix Mahfoud. Means and standard deviations of continuous variables are presented according to treatment group. Smith, P. Renal sympathetic denervation therapy for resistant hypertension: a contemporary synopsis and future implications. Kraus, Chandru P. Calhoun. ASIRVATHAM. (2016) Evidence for a critical role of the sympathetic nervous system in hypertension. Kidneys also regulate fluid balance and blood pressure. Popov. However, a significant effect on systolic blood pressure was not observed. Adobe Flash Player is required to view this feature. Sundaram. Ruble, C. At 6 months, patients in the control group were allowed to cross over to undergo denervation if they still met the inclusion criteria for the study. (2016) Anatomic Patterns of Renal Arterial Sympathetic Innervation: New Aspects for Renal Denervation. (2016) Bradykinin receptor blockade restores the baroreflex control of renal sympathetic nerve activity in cisplatin-induced renal failure rats. CrossRef 61 Peter L. Statistical Analysis This trial was powered for the primary safety and efficacy end points and for the change in mean 24-hour ambulatory systolic blood pressure at 6 months (secondary efficacy end point). CrossRef 20 Dominik Linz, Giuseppe Mancia, Felix Mahfoud, Krzysztof Narkiewicz, Luis Ruilope, Markus Schlaich, Ingrid Kindermann, Roland E. The sponsor had the right to review but not approve the final manuscript. CrossRef 116 Charalambos Antoniades, Gemma Vilahur. (2016) Controversies Surrounding Renal Denervation: Lessons Learned From Real-World Experience in Two United Kingdom Centers. E. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The primary safety end point was a composite of major adverse events, defined as death from any cause, end-stage renal disease, an embolic event resulting in end-organ damage, renal-artery or other vascular complications, or hypertensive crisis within 30 days or new renal-artery stenosis of more than 70% within 6 months. Between-group differences and differences from baseline to the 6-month follow-up assessment were tested with the use of unpaired and paired t-tests, respectively. Sharp, Justin E. When renal function, measured by the glomerular filtration rate, is persistently poor, dialysis and kidney transplantation may be treatment options. (2016) Early pre-occlusive bilateral renal artery stenosis after renal denervation. Callans, Emile G Daoud, Paolo Della-Bella, Kevin P. Karjalainen. Ng, Manish Saxena, Felix Mahfoud, Atul Pathak, Melvin D. POWERS, SARAH WEBER, MALINI MADHAVAN, YONG-MEI CHA, SURAJ KAPA, SAMUEL J. (2016) Effects of Spironolactone and Renal Denervation Treatment on Blood Pressure and Its Variability—Different Aspects of Hypertension Treatment. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Linde. (2016) Renal denervation for resistant hypertension: no. Journal of the American Society of Hypertension 10:6, 510-516. (2016) Blood Pressure Responses to Endovascular Stimulation: A Potential Therapy for Autonomic Disorders With Vasodilatation. 2017. Journal of the American Society of Hypertension 10:11, 838-846. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) Chronic Kidney Disease As a Potential Indication for Renal Denervation. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Reekers, Costas Tsioufis, Dierk Vorwerk, Roland E. Medication changes between screening visits may have caused instability of baseline blood pressure, but only 31 patients (5. Textor, Lilach O. After accounting for expected patient attrition, we calculated that we would need to enroll a total of 530 patients. (2016) New strategies to tackle diabetic kidney disease. Pathogenesis of Macrovascular Complications in Diabetes. Clinical and Experimental Pharmacology and Physiology 44:2, 162-171. Calhoun. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. An operator learning curve can affect the success of interventional procedures, though all procedures were proctored. Meuth, Meinrad Gawaz, Axel Bauer, Harald F. Carter. The kidneys are two bean -shaped organs found on the left and right sides of the body in vertebrates. Journal of the American College of Cardiology 68:18, 2016-2025. Golder. Adobe Flash Player is required to view this feature. Results of treatment of patients with hypertension by total thoracic and partial to total lumbar sympathectomy, splanchnicectomy and celiac ganglionectomy. Adobe Flash Player is required to view this feature. Knuepfer. K. Rick Turner, John Lee. 2017. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Journal of the American Society of Hypertension 10:8, 656-670. conventional main renal artery treatment. CrossRef 114 Heejung Bang. (2016) A practical approach for measurement of antihypertensive medication adherence in patients with resistant hypertension. Brady, Dhanansayan Shanmuganayagam, Serge D. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Paterson. H. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Rossignol, S. (2016) Spironolactone versus renal nerve denervation for treatment of uncontrolled resistant hypertension. The trial was designed by the first and last authors and the sponsor (Medtronic). We observed no significant difference in outcomes between operators performing five or more procedures and those performing fewer than five procedures, and we found no evidence of a learning curve for high-volume operators when earlier procedures were compared with later ones. Duprez. The kidneys also produce hormones including calcitriol and erythropoietin. (2016) Interventionelle Hypertonietherapie. Mentz, S. Khalsa, Rajesh Kumar, Richard Lane, Aman Mahajan, Sunny Po, Peter J. Abdulla, M. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. CrossRef 156 N. Henine, B. CrossRef 122 Murray Epstein, Daniel A. (2016) The impact of renal sympathetic denervation on cardiac electrophysiology and arrhythmias: A systematic review of the literature. 6 Smithwick RH, Thompson JE. CrossRef 101 Xiaojuan Zhang, Nie Wu, Wenjuan Yan, Chunya Zhou, Hua Guo. (2016) Highlights of the 2015 ERA-EDTA congress: chronic kidney disease, hypertension. Laffin, George L. Adobe Flash Player is required to view this feature. There was no direct measurement to confirm that the renal nerves were in fact denervated by the procedure, because there is no test that can be easily performed in a large trial. A blinding index, based on responses to a questionnaire, was calculated at hospital discharge and at 6 months to verify the effectiveness of blinding. (2017) Denervation of the distal renal arterial branches vs. Media in This Article Figure 1 Primary Efficacy End Point. Calhoun, Heitor Moreno, Rodrigo Modolo. They are also responsible for the reabsorption of water, glucose, and amino acids. All patients are to be followed semiannually through 5 years after randomization. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. Harvard Clinical Research Institute independently validated the analyses, with funding from the sponsor. (2016) Renal denervation for resistant hypertension. Black. Adobe Flash Player is required to view this feature. (2016) Physician-pharmacist collaboration versus usual care for treatment-resistant hypertension. Zucker. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) A Perspective on the Delivery of Renal Denervation Therapy Based on Pre-Clinical Data. Johns. Renal physiology is the study of kidney function, while nephrology is the medical specialty concerned with kidney diseases. (2016) Translational neurocardiology: preclinical models and cardioneural integrative aspects. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Kichou, L. Schroeder, Ole Lederballe, Hans Rickers, Ulla Kampmann, Per L. CrossRef 126 Leonard A. Bakris. (2016) Endpoint design for future renal denervation trials — Novel implications for a new definition of treatment response to renal denervation. Renal denervation in the current trial appeared to be safe, with no unanticipated side effects. Loewy, Mark M. (2016) New Evidence Supporting the Use of Mineralocorticoid Receptor Blockers in Drug-Resistant Hypertension. Resistant hypertension: diagnosis, evaluation, and treatment -- a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. (2016) Long-term effects of multielectrode renal denervation on cardiac adaptations in resistant hypertensive patients with left ventricular hypertrophy. Nadim, N. (2016) Modern Challenges in Treating Hypertension. (2016) Laparoscopic Renal Denervation for Uncontrolled Hypertension Due to Medication Intolerance: A Case Report. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. End Points The results with regard to the primary efficacy end point (change in office systolic blood pressure at 6 months) and the secondary efficacy end point for which the study was powered (change in ambulatory blood pressure at 6 months) are shown in Figure 1 Figure 1 Primary Efficacy End Point. Adobe Flash Player is required to view this feature. (2016) Renal Denervation for Resistant Hypertension. Burchell, Kenneth Chan, Laura E. L. Bell, Kamal Rahmouni. CrossRef 107 Jill Bunker, Choon-Lan Chang, Neil Chapman, Neil Poulter, Simon Thom, Lucy Thornton-Jones, Peter Sever. (2016) Leptin as a Mediator of Obesity-Induced Hypertension. Webb. CrossRef 135 Kazuomi Kario, Tomokazu Ikemoto, Mitsuo Kuwabara, Hiromi Ishiyama, Kimiyo Saito, Satoshi Hoshide. CrossRef 130 Francesca Mallamaci. They also move waste products out of the blood and into the urine, such as nitrogen-containing urea and ammonium. Clinical exclusion criteria were known secondary causes of hypertension and more than one hospitalization for a hypertensive emergency in the previous year. (2016) Emerging concepts for patients with treatment-resistant hypertension. Hart, Rohit Ramchandra, Julian F. CrossRef 160 Deepak L. Further evaluation in rigorously designed clinical trials will be necessary to validate alternative methods of renal denervation or to confirm previously reported benefits of renal denervation in patients with resistant hypertension. Moss, Anna-Maria Belli, Antonio Coca, Michael Lee, Giuseppe Mancia, Jan H. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. For the next 2 weeks, patients recorded their blood pressure at home (hereafter referred to as home blood pressure) in the morning and in the evening and kept a diary indicating their adherence to medical therapy. The American Journal of the Medical Sciences 353:1, 27-30. (2016) Current Status of Renal Denervation in Hypertension. Spironolactone in Resistant Hypertension: Effects on Circadian Patterns and Blood Pressure Variability. Jackson, Kalyanam Shivkumar, Samir Saba, John Sapp, William G. CrossRef 60 Jose Carlos Prado, Dayan Salado, Luis Miguel Ruilope, Julian Segura. The between-group difference (the primary efficacy end point) did not meet a test of superiority with a margin of 5 mm Hg. org). If you are using an operating system that does not support Flash, we are working to bring you alternative formats. 5 at discharge and at the 6-month follow-up visit, indicating proper blinding. (2016) Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials. 5 indicating successful blinding. Adobe Flash Player is required to view this feature. (2016) Resistant Hypertension and the Pivotal Role for Mineralocorticoid Receptor Antagonists: A Clinical Update 2016. Ardell, Kalyanam Shivkumar. (2016) Renal sympathetic denervation for treatment of patients with atrial fibrillation: Reappraisal of the available evidence. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 161 Murray Epstein. Adobe Flash Player is required to view this feature. Blankestijn. Both patients and assessors may be subject to bias in favor of a new treatment that is expected to have increased efficacy. Langer. CrossRef 44 Helen Triantafyllidi, Chrysa Arvaniti, Leonidas Palaiodimos, Stefanos Vlachos, Antonios Schoinas, Chrysanthi Batistaki, Georgia Kostopanagiotou, John Lekakis. (2016) Random guess and wishful thinking are the best blinding scenarios. P. (2016) The future of renal denervation. (2017) Effects of percutaneous renal sympathetic denervation on cardiac function and exercise tolerance in patients with chronic heart failure. Blankestijn. Al-Khatib. Schiller, Peter Ricci Pellegrino, Irving H. Probstfield, Mahboob Rahman, Henry R. The majority of patients were receiving hydrochlorothiazide (Table S3 in the Supplementary Appendix ). The body-mass index is the weight in kilograms divided by the square of the height in meters. Mankin. The most common adult renal cancer is renal cell carcinoma. CrossRef 111 Joana Delgado Silva, Marco Costa, Bernard J. (2016) Screening for non-adherence to antihypertensive treatment as a part of the diagnostic pathway to renal denervation. Adobe Flash Player is required to view this feature. (2016) Treatment-Resistant Hypertension and Outcomes Based on Randomized Treatment Group in ALLHAT. Duff, H. R. 2016. Garberich, Mary Daniels, Robert S. (2016) Sympathetic innervation of the kidney in health and disease: Emphasis on the role of purinergic cotransmission. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) Preliminary effects of renal denervation with saline irrigated catheter on cardiac systolic function in patients with heart failure. M. CrossRef 139 Stefano Taddei, Elisa Dal Canto, Rosa Maria Bruno. Adobe Flash Player is required to view this feature. Study Treatment Patients in the treatment group underwent renal-artery denervation with the use of radiofrequency energy delivered by the Symplicity renal-denervation catheter (Medtronic). Clinical Journal of the American Society of Nephrology. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation -- a VA cooperative study. (2017) Effects of renal sympathetic denervation on the stellate ganglion and brain stem in dogs. (2017) Systematische Fehler in klinischen Studien. However, the Symplicity catheter system allowed confirmation of energy delivery, and the presence of angiographic notching indicated a biologic effect of energy delivery on the artery. Schmieder. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 88 David A. (2016) The effect of renal denervation on resistant hypertension: Meta-analysis of randomized controlled clinical trials. A significant change from baseline to 6 months in ambulatory 24-hour average systolic blood pressure was observed in both groups. The trial was not powered to detect small differences in systolic or diastolic blood pressure or any potential effects in subgroups. (2016) Renal Denervation Reverses Hepatic Insulin Resistance Induced by High-Fat Diet. Journal of the American Society of Hypertension 10:4, 307-317. (2016) Catheter-Based Renal Denervation Reduces Hypoxia-Triggered Nocturnal Blood Pressure Peak in Obstructive Sleep Apnea Syndrome. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2017) Effects of renal sympathetic denervation on blood pressure, sleep apnoea severity and metabolic indices: a prospective cohort study. The between-group difference (the secondary efficacy end point for which the study was powered) did not meet a test of superiority with a margin of 2 mm Hg. Schlaich, Wilko Spiering, Pim. (2017) Efficacy and Safety of Renal Sympathetic Denervation on Dogs with Pressure Overload-Induced Heart Failure. White. CrossRef 177 Weijie Chen, Zhiyu Ling, Yanping Xu, Zengzhang Liu, Li Su, Huaan Du, Peilin Xiao, Xianbin Lan, Qijun Shan, Yuehui Yin. CrossRef 7 W. Adobe Flash Player is required to view this feature. (2016) Renal denervation in hypertensive patients not on blood pressure lowering drugs. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2017) Pathophysiologic Mechanisms in Heart Failure: Role of the Sympathetic Nervous System. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Lobo. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Ratcliffe, Emma C. Renal sympathetic denervation in patients with treatment-resistant hypertension (the SYMPLICITY HTN-2 Trial): a randomised controlled trial. Geller, S. (2016) Renal Denervation vs Pharmacotherapy for Resistant Hypertension: A Meta-Analysis. CrossRef 10 Lena Rivard, Jason Andrade. Irish Journal of Medical Science (1971 -) 185:3, 635-641. (2016) The effects of renal denervation on resistant hypertension patients. Adobe Flash Player is required to view this feature. Jandeleit-Dahm. (2017) Innovative Approaches to Arrhythmic Storm: The Growing Role of Interventional Procedures. Pedersen, Anne Kaltoft. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. 2017. Schlaich. Lobo, Andreas Baumbach. Adobe Flash Player is required to view this feature. CrossRef 150 Thomas Stiermaier, Thomas Okon, Karl Fengler, Ulrike Mueller, Robert Hoellriegel, Gerhard Schuler, Steffen Desch, Philipp Lurz. Menne, R. K. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Marrouche, Allison Payne. (The blinding procedure is detailed in the Supplementary Appendix, available at NEJM. Bisognano. Airaksinen, Tuomas Paana, Pasi P. (2016) Soluble vascular endothelial growth factor receptor-1 is reduced in patients with resistant hypertension after renal denervation.
CrossRef 112 Dasheng Lu, Kai Wang, Qian Liu, Shengchan Wang, Qi Zhang, Qijun Shan. Adobe Flash Player is required to view this feature. (2016) Executive summary of the joint position paper on renal denervation of the Cardiovascular and Interventional Radiological Society of Europe and the European Society of Hypertension. The observations regarding systolic blood pressure were consistent when diastolic blood pressure was examined (Table S5 in the Supplementary Appendix ). Hayek, Chandan Devireddy. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) Renal Denervation Improves the Baroreflex and GABA System in Chronic Kidney Disease-induced Hypertension. Schmieder, Christian Ott, Peter Bramlage. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. CrossRef 23 Hsin-Hung Chen, Pei-Wen Cheng, Wen-Yu Ho, Pei-Jung Lu, Chi-Cheng Lai, Yang-Ming Tseng, Hua-Chang Fang, Gwo-Ching Sun, Michael Hsiao, Chun-Peng Liu, Ching-Jiunn Tseng. In agreement with the Food and Drug Administration, the superiority of denervation over the sham procedure was established by a margin of 5 mm Hg for the primary efficacy end point and by a margin of 2 mm Hg for the secondary efficacy end point. Zannad, R. (2016) Device Therapies for Resistant Hypertension. CrossRef 95 Dongdong Sun, Chuang Li, Mei Li, Jielin Liu, Shaojun Wen. CrossRef 5 Dagmara Hering, Pawel J Winklewski. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The numbers and types of antihypertensive medications at 6 months were similar to those at baseline in both groups. Schlaich, Carl Schultz, Sharad Shetty. Adobe Flash Player is required to view this feature. (2016) Renal Artery Vasodilation May Be An Indicator of Successful Sympathetic Nerve Damage During Renal Denervation Procedure. A significant change from baseline to 6 months in office systolic blood pressure was observed in both study groups. (2016) Clinical neurocardiology defining the value of neuroscience-based cardiovascular therapeutics. (2016) Accessory renal arteries: Prevalence in resistant hypertension and an important role in nonresponse to radiofrequency renal denervation. CrossRef 81 Guram Imnadze, Stefan Balzer, Baerbel Meyer, Joerg Neumann, Rainer Horst Krech, Joachim Thale, Norbert Franz, Henning Warnecke, Khaled Awad, Salim S. (2016) Eppur Si Muove: The dynamic nature of physiological control of renal blood flow by the renal sympathetic nerves. Cooper. Addition of Spironolactone in Patients with Resistant Arterial Hypertension (ASPIRANT): a randomized, double-blind, placebo-controlled trial. CrossRef 46 Alexander Briasoulis, George L. (2017) Present and Future of Interventional Treatment of Resistant Hypertension. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Owing to the 2:1 randomization ratio, 158 patients were required for the control group. (2016) Non-invasive Renal Denervation: Update on External Ultrasound Approaches. There were no significant differences between the two groups. (2016) Use of Biomarkers in the Evaluation and Treatment of Hypertensive Patients. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Table S4 in the Supplementary Appendix shows that the blinding index was significantly greater than 0. (2016) Renal denervation for resistant hypertension: yes. (2016) Interventional procedures and future drug therapy for hypertension. Journal of the American Society of Hypertension 10:5, 393-395. CrossRef 133 Yusuke Sata, Markus P. CrossRef 92 Yong Wei, Juan Xu, Genqing Zhou, Songwen Chen, Ping Ouyang, Shaowen Liu, Jaap A. CrossRef 163 Geoffrey Burnstock, Andrzej Loesch. Free Full Text 77 N Eikelis, D Hering, P Marusic, A S Walton, E A Lambert, Y Sata, H Krum, G W Lambert, M D Esler, M P Schlaich. Zubanova, Sergei V. The kidneys regulate the balance of ions known as electrolytes in the blood, along with maintaining acid base homeostasis. CrossRef 16 Jun-Qing Gao, Yun Xie, Wei Yang, Jian-Pu Zheng, Zong-Jun Liu. Paton. CrossRef 168 Hafid Narayan, David J. Adobe Flash Player is required to view this feature. Krauss. Bisognano, Y. The baseline characteristics are shown in Table 1 Table 1 Baseline Characteristics of the Study Population. (2016) Resistance to renal denervation therapy — Identification of underlying mechanisms by analysis of differential DNA methylation. Patients were receiving an average of five antihypertensive medications, and on average, four of these medications were at maximally tolerated doses (Table S2 in the Supplementary Appendix ). End Points The primary efficacy end point was the mean change in office systolic blood pressure from baseline to 6 months in the denervation group, as compared with the mean change in the sham control group, with a superiority margin of 5 mm Hg. 8%, which was derived from historical data. (2016) The future for renal denervation depends on embracing the lessons learned from our previous studies. Journal of the American Society of Hypertension 10:5, 457-466. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the SYMPLICITY HTN-2 randomized, controlled trial. Regardless, this finding has important therapeutic implications for the design of trials of antihypertensive (and other) medications, devices, and strategies. Rigor in Biomedical Science. They also control the ion concentrations and acid-base balance of the blood. (2016) Reductions of left ventricular mass and atrial size following renal denervation: a meta-analysis. CrossRef 127 Duygu Batu Demir, Mark E. CrossRef 34 Christian Ott, Felix Mahfoud, Axel Schmid, Sebastian Ewen, Stefan W. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Critical Reviews in Clinical Laboratory Sciences 54:1, 18-25. J Am Coll Cardiol 2013 November 25 (Epub ahead of print). Discussion This randomized, sham-controlled, blinded trial did not show a benefit of renal-artery denervation with respect to either of the efficacy end points for which the study was powered (reduction in office or ambulatory systolic blood pressure at 6 months). Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4,121 patients with focus on trial design: the CONVERGE report. (2016) Executive Summary of the Joint Position Paper on Renal Denervation of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the European Society of Hypertension (ESH). Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. CrossRef 4 Florrie Daniels, Simon De Freitas, Andrew Smyth, John Garvey, Conor Judge, John Joseph Gilmartin, Faisal Sharif. Neural Control of Cardiac Function in Health and Disease. Reekers, Costas Tsioufis, Dierk Vorwerk, Roland E. Shown are between-group differences in the change in office systolic blood pressure from baseline to 6 months in selected subgroups. Surface projections of the organs of the trunk, showing kidneys at the level of T12 to L3. Human kidneys viewed from behind with spine removed. (2016) Cardiac sympatho-vagal balance and ventricular arrhythmia. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. Although they are not normally harmful, kidney stones can be extremely painful. Abstract Background Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. The responses with regard to systolic and diastolic blood pressure were significantly greater in the denervation group than in the sham-procedure group. We found no evidence of a significant difference in medication adherence between the groups. e. Hypertension: Implications of Current JNC 8 Guidelines on Treatment. The study was also powered for assessment of a secondary efficacy end point: the change in mean 24-hour ambulatory systolic blood pressure at 6 months. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 25 Rosario Cianci, Biagio Barbano, Antonietta Gigante, Edoardo Rosato, Alvaro Zaccaria, Nicola Mangialardi. Sobotka, Atul Pathak. Zipes. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 3 Wei-Chung Tsai, Yi-Hsin Chan, Kroekkiat Chinda, Zhenhui Chen, Jheel Patel, Changyu Shen, Ye Zhao, Zhaolei Jiang, Yuan Yuan, Michael Ye, Lan S. CrossRef 128 S. Anatomical exclusion criteria were renal-artery stenosis of more than 50%, renal-artery aneurysm, prior renal-artery intervention, multiple renal arteries, a renal artery of less than 4 mm in diameter, or a treatable segment of less than 20 mm in length. Pocock, J. CrossRef 90 J. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. 05. (2017) R1 autonomic nervous system in acute kidney injury. Joles. The first and last authors accept full responsibility for the accuracy and completeness of the reported analyses and interpretations of the data, and they vouch for the fidelity of the study to the protocol (available with full text of this article at NEJM. Current Opinion in Nephrology and Hypertension 25:4, 348-354. CrossRef 38 Weijie Chen, Huaan Du, Jiayi Lu, Zhiyu Ling, Yi Long, Yanping Xu, Peilin Xiao, Laxman Gyawali, Kamsang Woo, Yuehui Yin, Bernhard Zrenner. Journal of Cardiovascular Pharmacology and Therapeutics 21:4, 344-352. Somers, Miguel Valderrabano, Marmar Vaseghi, Douglas P. Renal Denervation for Resistant Hypertension. CrossRef 99 Murray Esler, Ling Guo. Bhatt. Cooper, Karin A. Adobe Flash Player is required to view this feature. Divergent results using clinic and ambulatory blood pressures: report of a darusentan-resistant hypertension trial. Andrew Armour, Peng-Sheng Chen, Murray Esler, Gaetano M. org. Adobe Flash Player is required to view this feature. CrossRef 169 Udho Thadani, Nguyen Duc Cong. (2016) The Potential Role of Catheter-Based Renal Sympathetic Denervation in Chronic and End-Stage Kidney Disease. A. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Gassler, John D. (2016) Renal Denervation in Patients With Uncontrolled Hypertension and Confirmed Adherence to Antihypertensive Medications. On the basis of the 9. CrossRef 26 Rolf Wachter, Marcel Halbach, George L. Cardiovascular protection and blood pressure reduction: a meta-analysis. Schmieder. Schwartz. CrossRef 56 C Tsioufis, V Papademetriou, K Dimitriadis, A Kasiakogias, A Kordalis, E Andrikou, A Milkas, I Liatakis, E O-Y Lau, D Tousoulis. Diseases of the kidney are diverse, but individuals with kidney disease frequently display characteristic clinical features. CrossRef 134 Gemma Currie, Christian Delles. CrossRef 68 Christian Ukena, Felix Mahfoud, Sebastian Ewen, Andreas Bollmann, Gerhard Hindricks, Boris A. CrossRef 164 Martin J Wolley, Michael Stowasser. (2016) Renal sympathetic denervation using MR-guided high-intensity focused ultrasound in a porcine model. CrossRef 12 Jun-Qing Gao, Yun Xie, Wei Yang, Jian-Pu Zheng, Zong-Jun Liu. (2016) Trained breathing-induced oxygenation acutely reverses cardiovascular autonomic dysfunction in patients with type 2 diabetes and renal disease. Perhaps this placebo effect was accentuated by the use of an invasive procedure in the control group (i. Journal of the American Society of Hypertension 10:5, 396-398. Adobe Flash Player is required to view this feature. Cancers, cysts, and some other renal conditions can be managed with removal of the kidney. The objective performance criterion for the primary safety end point was a rate of major adverse events of 9. (2016) Resistant Hypertension and Chronic Kidney Disease: a Dangerous Liaison. , a femoral-artery puncture and renal angiography), which may have increased adherence to medication and diet. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. Sunagawa, I. (2016) True Resistant Hypertension Following Observed Drug Ingestion: A Systematic Evaluation. ) Blood-pressure assessors were also unaware of the study-group assignments. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 66 Dagmara Hering, Carl Schultz, Markus P. (2016) A cholinergic-sympathetic pathway primes immunity in hypertension and mediates brain-to-spleen communication. (2016) Device-based Therapy for Hypertension. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. Thompson. Moss, Anna-Maria Belli, Antonio Coca, Michael Lee, Giuseppe Mancia, Jan H. Chandler, Angelo Sinopoli. 25 Although blood pressure was not always measured in the morning, it was measured at approximately the same time at both the baseline and the 6-month follow-up visits. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. CrossRef 115 Felix Mahfoud, George Bakris, Deepak L. CrossRef 57 M. Resistant hypertension: a frequent and ominous finding among hypertensive patients with atherothrombosis. No changes in antihypertensive medication in the previous 2 weeks were allowed. Blankestijn, Michiel Voskuil, Jeff M Sands. CrossRef 176 Pasquale Esposito, Roberto Mereu, Giacomo De Barbieri, Teresa Rampino, Alessandro Di Toro, Per-Henrik Groop, Antonio Dal Canton, Luciano Bernardi. Renal denervation and left ventricular mass regression: a benefit beyond blood pressure reduction. Patients were unaware of whether they underwent renal-artery denervation or renal angiography only (sham control). (2016) Novel mechanisms in the pathogenesis of atrial fibrillation: practical applications. The International Journal of Cardiovascular Imaging 32:6, 855-862. CrossRef 18 J. (2016) Renal Denervation: a Field in Flux. Introduction—Opportunities and Challenges. Adobe Flash Player is required to view this feature. (2016) Neural modulation for hypertension and heart failure. (2016) Infiltration of the sphenopalatine ganglion decreases blood pressure in newly diagnosed and never treated patients with essential hypertension. The proportions of patients with a reduction in office systolic or diastolic blood pressure of at least 5 mm Hg or at least 10 mm Hg are shown in Table S6 in the Supplementary Appendix. Predictors and outcomes of resistant hypertension among patients with coronary artery disease and hypertension. CrossRef 63 Paige VonAchen, Jason Hamann, Thomas Houghland, John R. Changes in antihypertensive medication were not allowed during the 6-month follow-up period unless they were considered to be clinically necessary. CrossRef 104 Manish Kalla, Neil Herring, David J. CrossRef 167 Guido Grassi, Venkata S. (2016) Second denervation in a patient with resistant hypertension. CrossRef 73 Daniela Carnevale, Marialuisa Perrotta, Fabio Pallante, Valentina Fardella, Roberta Iacobucci, Stefania Fardella, Lorenzo Carnevale, Raimondo Carnevale, Massimiliano De Lucia, Giuseppe Cifelli, Giuseppe Lembo. Wachter. 2016. Gray, Elyse Di Marco, Riccardo Candido, Mark E. (2017) Effects of percutaneous renal sympathetic denervation on cardiac function and exercise tolerance in patients with chronic heart failure. CrossRef 17 Gregory Curfman. Adobe Flash Player is required to view this feature. CrossRef 45 Weijie Chen, Zhiyu Ling, Huaan Du, Wenxin Song, Yanping Xu, Zengzhang Liu, Li Su, Peilin Xiao, Yuelong Yuan, Jiayi Lu, Jianhong Zhang, Zhifeng Li, Jiang Shao, Bin Zhong, Bei Zhou, Kamsang Woo, Yuehui Yin. (2016) Scientists of Tomorrow at the Frontiers of Cardiovascular Biology 2016 in Florence: translating basic science into clinical practice is the next frontier. (2016) The effect of two different renal denervation strategies on blood pressure in resistant hypertension: Comparison of full-length versus proximal renal artery ablation. Adobe Flash Player is required to view this feature. The kidneys also make an important enzyme, renin, which affects blood pressure through negative feedback. CrossRef 155 Enrico Boschetti, Yahya Alrashdi, Giuseppe Schillaci. Lerman. Adobe Flash Player is required to view this feature. The between-group difference (the primary efficacy end point) did not meet a test of superiority with a margin of 5 mm Hg. A. Adobe Flash Player is required to view this feature. Study Patients Patients with severe resistant hypertension were prospectively enrolled in the study. Journal of the American College of Cardiology 68:16, 1723-1726. Ram. Each kidney feeds urine into the bladder by means of a tube known as the ureter. CrossRef 151 P Patel, P K C Gupta, C M J White, A G Stanley, B Williams, M Tomaszewski. Bakris. Ideally, blood pressure would have been measured in the morning as recommended by the American Heart Association. Zucker. CrossRef 67 George Bazoukis, Panagiotis Korantzopoulos, Costas Tsioufis. Clegg, Cathryn Kolka. Adobe Flash Player is required to view this feature. H. Kichou, M. CrossRef 9 Paul Erne, Isabella Sudano, Therese J. 2016. J. Adobe Flash Player is required to view this feature. CrossRef 31 Wail Nammas, Juhani K. Tonino, Willemien L. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) Endovascular ultrasound for renal sympathetic denervation in patients with therapy-resistant hypertension not responding to radiofrequency renal sympathetic denervation. CrossRef 145 Andrew S. Adobe Flash Player is required to view this feature. CrossRef 75 Martine M. Journal of the American Society of Hypertension 10:5, 390-392. 8% safety performance criterion, 316 patients were required in the renal-denervation group to provide 80% power, with the use of a one-sided significance level of 0. They filter the blood in order to make urine, to release and retain water, and to remove waste. CrossRef 147 Mohammed Awais Hameed, Mark Pucci, Una Martin, Richard Watkin, Sagar Doshi, Jonathan Freedman, Peter Riley, Jonathan Townend, Paul Crowe, Graham Lipkin, Indranil Dasgupta. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. A. CrossRef 170 Yuanqing Yao, Dengqing Zhang, Jun Qian, Shimin Deng, Yuwen Huang, Jing Huang. (2016) Renal Denervation in a Real Life Setting: A Gradual Decrease in Home Blood Pressure. Adobe Flash Player is required to view this feature. Recruitment to a clinical trial improves glycemic control in patients with diabetes. A significant change from baseline to 6 months in office systolic blood pressure was observed in both study groups. (2016) Evaluating the carotid bodies and renal nerves as therapeutic targets for hypertension. (2016) Splitting atoms: the Endocrine Society guideline for the management of primary aldosteronism. Weiss, Kurt Huber, Clemens Steinwender. Then a confirmatory screening visit occurred, during which the systolic blood pressure of 160 mm Hg or higher was confirmed, adherence to medications was documented, and automated 24-hour ambulatory blood-pressure monitoring was performed to ensure a systolic blood pressure of 135 mm Hg or higher. CrossRef 14 Steve Antoine, Gaurang Vaidya, Haider Imam, Daniel Villarreal. Results A total of 535 patients underwent randomization. (2016) Renal Denervation Suppresses the Inducibility of Atrial Fibrillation in a Rabbit Model for Atrial Fibrosis. Between-group differences in the change in office systolic blood pressure from baseline to 6 months in various prespecified subgroups are shown in Figure 3 Figure 3 Selected Subgroup Analyses. 22,23 Our analysis revealed that an important placebo effect was present. A significant change from baseline to 6 months in ambulatory 24-hour average systolic blood pressure was observed in both groups. Rousselle. 8%) had a medication change during this period, with no significant between-group difference in office blood pressure at screening visits (Table S2 in the Supplementary Appendix ). Methods We designed a prospective, single-blind, randomized, sham-controlled trial. Regression to the mean: what it is and how to deal with it. (2016) CNS sites activated by renal pelvic epithelial sodium channels (ENaCs) in response to hypertonic saline in awake rats. Finally, the results of this trial are specific to the catheter tested and cannot necessarily be generalized to other denervation systems. (2016) Renal denervation in treatment-resistant essential hypertension. Gums, Barry L. The between-group difference (the secondary efficacy end point for which the study was powered) did not meet a test of superiority with a margin of 2 mm Hg. Beeftink, Wilko Spiering, Michiel L. CrossRef 71 Morris J Brown, William M Drake. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. (2016) Update in Hypertension Therapy. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Citing Articles 1 Pingan Chen, Shuilong Leng, Yishan Luo, Shaonan Li, Zicheng Huang, Zhenxi Liu, Zhen Liu, Jie Wang, Xiaoming Lei. Located at the rear of the abdominal cavity in the retroperitoneal space, the kidneys receive blood from the paired renal arteries, and drain into the paired renal veins. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. (2016) Renal artery sympathetic denervation: observations from the UK experience. Willis, F. Adobe Flash Player is required to view this feature. The misattribution of a placebo effect as a treatment effect is a likely limitation of prior renal-denervation studies. Lesser, Yale Wang, David Caye, Kristi Rosenthal, Ross F. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Schlaich. Adobe Flash Player is required to view this feature. Caulfield, Indranil Dasgupta. The first and last authors prepared the first draft of this manuscript, which was then reviewed and edited by the coauthors. CrossRef 141 Christopher J. Kalman, Prashanthan Sanders.
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