Skip to main content
Top
Published in: Clinical Research in Cardiology 9/2016

Open Access 01-09-2016 | Original Paper

Renal denervation in hypertensive patients not on blood pressure lowering drugs

Authors: Rosa L. De Jager, Margreet F. Sanders, Michiel L. Bots, Melvin D. Lobo, Sebastian Ewen, Martine M. A. Beeftink, Michael Böhm, Joost Daemen, Oliver Dörr, Dagmara Hering, Felix Mahfoud, Holger Nef, Christian Ott, Manish Saxena, Roland E. Schmieder, Markus P. Schlaich, Wilko Spiering, Pim. A. L. Tonino, Willemien L. Verloop, Eva E. Vink, Evert-Jan Vonken, Michiel Voskuil, Stephen G. Worthley, Peter J. Blankestijn

Published in: Clinical Research in Cardiology | Issue 9/2016

Login to get access

Abstract

Introduction

Studies on the blood pressure lowering effect of renal denervation (RDN) in resistant hypertensive patients have produced conflicting results. Change in medication usage during the studies may be responsible for this inconsistency. To eliminate the effect of medication usage on blood pressure we focused on unmedicated hypertensive patients who underwent RDN.

Methods and results

Our study reports on a cohort of patients, who were not on blood pressure lowering drugs at baseline and during follow-up, from eight tertiary centers. Data of patients were used when they were treated with RDN and had a baseline office systolic blood pressure (SBP) ≥140 mmHg and/or 24-h ambulatory SBP ≥130 mmHg. Our primary outcome was defined as change in office and 24-h SBP at 12 months after RDN, compared to baseline. Fifty-three patients were included. There were three different reasons for not using blood pressure lowering drugs: (1) documented intolerance or allergic reaction (57 %); (2) temporary cessation of medication for study purposes (28 %); and (3) reluctance to take antihypertensive drugs (15 %). Mean change in 24-h SBP was −5.7 mmHg [95 % confidence interval (CI) −11.0 to −0.4; p = 0.04]. Mean change in office SBP was −13.1 mmHg (95 % CI −20.4 to −5.7; p = 0.001). No changes were observed in other variables, such as eGFR, body–mass-index and urinary sodium excretion.

Conclusion

This explorative study in hypertensive patients, who are not on blood pressure lowering drugs, suggests that at least in some patients RDN lowers blood pressure.
Appendix
Available only for authorised users
Literature
2.
go back to reference Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M (2010) Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 376:1903–1909CrossRefPubMed Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M (2010) Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 376:1903–1909CrossRefPubMed
3.
go back to reference Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD (2009) Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 361:932–934CrossRefPubMed Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD (2009) Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 361:932–934CrossRefPubMed
4.
go back to reference Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K et al (2009) Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 373:1275–1281CrossRefPubMed Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K et al (2009) Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 373:1275–1281CrossRefPubMed
5.
go back to reference Papademetriou V, Tsioufis CP, Sinhal A, Chew DP, Meredith IT, Malaiapan Y et al (2014) Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system. Hypertension 64:565–572. doi:10.1161/HYPERTENSIONAHA.114.03605 CrossRefPubMed Papademetriou V, Tsioufis CP, Sinhal A, Chew DP, Meredith IT, Malaiapan Y et al (2014) Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system. Hypertension 64:565–572. doi:10.​1161/​HYPERTENSIONAHA.​114.​03605 CrossRefPubMed
6.
go back to reference Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P et al (2015) Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet 385:1957–1965. doi:10.1016/S0140-6736(14)61942-5 CrossRefPubMed Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P et al (2015) Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet 385:1957–1965. doi:10.​1016/​S0140-6736(14)61942-5 CrossRefPubMed
7.
10.
go back to reference Blankestijn PJ, Alings M, Voskuil M, Grobbee DE (2015) The complexity after simplicity: how to proceed with renal denervation in hypertension? Eur J Prev Cardiol 22:412–414CrossRefPubMed Blankestijn PJ, Alings M, Voskuil M, Grobbee DE (2015) The complexity after simplicity: how to proceed with renal denervation in hypertension? Eur J Prev Cardiol 22:412–414CrossRefPubMed
12.
go back to reference Burnier M, Schneider MP, Chiolero A, Stubi CL, Brunner HR (2001) Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens 19:335–341CrossRefPubMed Burnier M, Schneider MP, Chiolero A, Stubi CL, Brunner HR (2001) Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens 19:335–341CrossRefPubMed
13.
go back to reference Jung O, Gechter JL, Wunder C, Paulke A, Bartel C, Geiger H et al (2013) Resistant hypertension? Assessment of adherence by toxicological urine analysis. J Hypertens 31:766–774CrossRefPubMed Jung O, Gechter JL, Wunder C, Paulke A, Bartel C, Geiger H et al (2013) Resistant hypertension? Assessment of adherence by toxicological urine analysis. J Hypertens 31:766–774CrossRefPubMed
14.
go back to reference Strauch B, Petrak O, Zelinka T, Rosa J, Somloova Z, Indra T et al (2013) Precise assessment of noncompliance with the antihypertensive therapy in patients with resistant hypertension using toxicological serum analysis. J Hypertens 31:2455–2461. doi:10.1097/HJH.0b013e3283652c61 CrossRefPubMed Strauch B, Petrak O, Zelinka T, Rosa J, Somloova Z, Indra T et al (2013) Precise assessment of noncompliance with the antihypertensive therapy in patients with resistant hypertension using toxicological serum analysis. J Hypertens 31:2455–2461. doi:10.​1097/​HJH.​0b013e3283652c61​ CrossRefPubMed
15.
16.
go back to reference Antoniou S, Saxena M, Hamedi N, de Cates C, Moghul S, Lidder S et al (2015) Management of hypertensive patients with multiple drug intolerances: a single-center experience of a novel treatment algorithm. J Clin Hypertens (Greenwich) 18(2):129–138. doi:10.1111/jch.12637 CrossRef Antoniou S, Saxena M, Hamedi N, de Cates C, Moghul S, Lidder S et al (2015) Management of hypertensive patients with multiple drug intolerances: a single-center experience of a novel treatment algorithm. J Clin Hypertens (Greenwich) 18(2):129–138. doi:10.​1111/​jch.​12637 CrossRef
17.
go back to reference Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M et al (2013) 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 31:1281–1357. doi:10.1097/01.hjh.0000431740.32696.cc CrossRefPubMed Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M et al (2013) 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 31:1281–1357. doi:10.​1097/​01.​hjh.​0000431740.​32696.​cc CrossRefPubMed
18.
go back to reference O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J et al (2002) Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 7:3–17CrossRefPubMed O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J et al (2002) Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 7:3–17CrossRefPubMed
20.
go back to reference Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D (1999) A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 130:461–470CrossRefPubMed Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D (1999) A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 130:461–470CrossRefPubMed
21.
go back to reference Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF III, Feldman HI et al (2009) A new equation to estimate glomerular filtration rate. Ann Intern Med 150:604–612CrossRefPubMedPubMedCentral Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF III, Feldman HI et al (2009) A new equation to estimate glomerular filtration rate. Ann Intern Med 150:604–612CrossRefPubMedPubMedCentral
22.
23.
go back to reference Verloop WL, Vink EE, Voskuil M, Vonken EJ, Rookmaaker MB, Bots ML et al (2013) Eligibility for percutaneous renal denervation: the importance of a systematic screening. J Hypertens 31:1662–1668CrossRefPubMed Verloop WL, Vink EE, Voskuil M, Vonken EJ, Rookmaaker MB, Bots ML et al (2013) Eligibility for percutaneous renal denervation: the importance of a systematic screening. J Hypertens 31:1662–1668CrossRefPubMed
26.
go back to reference Vink EE, Goldschmeding R, Vink A, Weggemans C, Bleijs RL, Blankestijn PJ (2014) Limited destruction of renal nerves after catheter-based renal denervation: results of a human case study. Nephrol Dial Transplant 29:1608–1610CrossRefPubMed Vink EE, Goldschmeding R, Vink A, Weggemans C, Bleijs RL, Blankestijn PJ (2014) Limited destruction of renal nerves after catheter-based renal denervation: results of a human case study. Nephrol Dial Transplant 29:1608–1610CrossRefPubMed
27.
go back to reference Kandzari DE, Bhatt DL, Sobotka PA, O’Neill WW, Esler M, Flack JM et al (2012) Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. Clin Cardiol 35:528–535CrossRefPubMed Kandzari DE, Bhatt DL, Sobotka PA, O’Neill WW, Esler M, Flack JM et al (2012) Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. Clin Cardiol 35:528–535CrossRefPubMed
28.
29.
go back to reference Chan TY, Woo KS, Nicholls MG (1992) The application of nebivolol in essential hypertension: a double-blind, randomized, placebo-controlled study. Int J Cardiol 35:387–395CrossRefPubMed Chan TY, Woo KS, Nicholls MG (1992) The application of nebivolol in essential hypertension: a double-blind, randomized, placebo-controlled study. Int J Cardiol 35:387–395CrossRefPubMed
34.
go back to reference Saruta T, Kageyama S, Ogihara T, Hiwada K, Ogawa M, Tawara K et al (2004) Efficacy and safety of the selective aldosterone blocker eplerenone in Japanese patients with hypertension: a randomized, double-blind, placebo-controlled, dose-ranging study. J Clin Hypertens (Greenwich) 6:175–183CrossRef Saruta T, Kageyama S, Ogihara T, Hiwada K, Ogawa M, Tawara K et al (2004) Efficacy and safety of the selective aldosterone blocker eplerenone in Japanese patients with hypertension: a randomized, double-blind, placebo-controlled, dose-ranging study. J Clin Hypertens (Greenwich) 6:175–183CrossRef
35.
go back to reference Saunders E, Smith WB, DeSalvo KB, Sullivan WA (2007) The efficacy and tolerability of nebivolol in hypertensive African American patients. J Clin Hypertens (Greenwich) 9:866–875CrossRef Saunders E, Smith WB, DeSalvo KB, Sullivan WA (2007) The efficacy and tolerability of nebivolol in hypertensive African American patients. J Clin Hypertens (Greenwich) 9:866–875CrossRef
36.
go back to reference Weinberger MH, Roniker B, Krause SL, Weiss RJ (2002) Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens 15:709–716CrossRefPubMed Weinberger MH, Roniker B, Krause SL, Weiss RJ (2002) Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens 15:709–716CrossRefPubMed
37.
go back to reference White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C et al (2011) Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension 57:413–420. doi:10.1161/HYPERTENSIONAHA.110.163402 CrossRefPubMed White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C et al (2011) Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension 57:413–420. doi:10.​1161/​HYPERTENSIONAHA.​110.​163402 CrossRefPubMed
38.
go back to reference White WB, Carr AA, Krause S, Jordan R, Roniker B, Oigman W (2003) Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinical blood pressure in patients with systemic hypertension. Am J Cardiol 92:38–42CrossRefPubMed White WB, Carr AA, Krause S, Jordan R, Roniker B, Oigman W (2003) Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinical blood pressure in patients with systemic hypertension. Am J Cardiol 92:38–42CrossRefPubMed
39.
go back to reference Rosa J, Widimsky P, Tousek P, Petrak O, Curila K, Waldauf P et al (2015) Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension 65:407–413. doi:10.1161/HYPERTENSIONAHA.114.04019 CrossRefPubMed Rosa J, Widimsky P, Tousek P, Petrak O, Curila K, Waldauf P et al (2015) Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension 65:407–413. doi:10.​1161/​HYPERTENSIONAHA.​114.​04019 CrossRefPubMed
40.
go back to reference Mahfoud F, Bohm M, Azizi M, Pathak A, Durand ZI, Ewen S et al (2015) Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J 36:2219–2227. doi:10.1093/eurheartj/ehv192 CrossRefPubMed Mahfoud F, Bohm M, Azizi M, Pathak A, Durand ZI, Ewen S et al (2015) Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J 36:2219–2227. doi:10.​1093/​eurheartj/​ehv192 CrossRefPubMed
41.
go back to reference Weber MA, Kirtane A, Mauri L, Townsend RR, Kandzari DE, Leon MB (2015) Renal denervation for the treatment of hypertension: making a new start, getting it right. J Clin Hypertens (Greenwich) 17:743–750. doi:10.1111/jch.12590 CrossRef Weber MA, Kirtane A, Mauri L, Townsend RR, Kandzari DE, Leon MB (2015) Renal denervation for the treatment of hypertension: making a new start, getting it right. J Clin Hypertens (Greenwich) 17:743–750. doi:10.​1111/​jch.​12590 CrossRef
42.
Metadata
Title
Renal denervation in hypertensive patients not on blood pressure lowering drugs
Authors
Rosa L. De Jager
Margreet F. Sanders
Michiel L. Bots
Melvin D. Lobo
Sebastian Ewen
Martine M. A. Beeftink
Michael Böhm
Joost Daemen
Oliver Dörr
Dagmara Hering
Felix Mahfoud
Holger Nef
Christian Ott
Manish Saxena
Roland E. Schmieder
Markus P. Schlaich
Wilko Spiering
Pim. A. L. Tonino
Willemien L. Verloop
Eva E. Vink
Evert-Jan Vonken
Michiel Voskuil
Stephen G. Worthley
Peter J. Blankestijn
Publication date
01-09-2016
Publisher
Springer Berlin Heidelberg
Published in
Clinical Research in Cardiology / Issue 9/2016
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-016-0984-y

Other articles of this Issue 9/2016

Clinical Research in Cardiology 9/2016 Go to the issue