Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry

M. F. Sanders; P. J. Blankestijn; M. Voskuil; W. Spiering; E. J. Vonken; J. I. Rotmans; B. L. van der Hoeven; J. Daemen; A. H. van den Meiracker; A. A. Kroon; M. W. de Haan; Marco Das; M. Bax; I. M. van der Meer; H. van Overhagen; B. J. H. van den Born; P. M. van Brussel; P. H. M. van der Valk; P. J. H. Smak Gregoor; M. Meuwissen; M. E. R. Gomes; T. Oude Ophuis; E. Troe; W. A. L. Tonino; C. J. A. M. Konings; P. A. M. de Vries; A. van Balen; J. E. Heeg; J. J. J. Smit; A. Elvan; R. Steggerda; S. M. L. Niamut; J. O. J. Peels; J. B. R. M. de Swart; A. J. Wardeh; J. H. M. Groeneveld; E. van der Linden; M. H. Hemmelder; R. Folkeringa; M. G. Stoel; G. D. Kant; J. P. R. Herrman; S. van Wissen; J. Deinum; S. W. Westra; W. R. M. Aengevaeren; K. J. Parlevliet; A. Schramm; G. A. J. Jessurun; B. J. W. M. Rensing; M. H. M. Winkens; T. K. A. Wierema; E. Santegoets; E. Lipsic; E. Houwerzijl; M. Kater; C. P. Allaart; A. Nap; M. L. Bots

Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry

M. F. Sanders, P. J. Blankestijn, M. Voskuil, W. Spiering, E. J. Vonken, J. I. Rotmans, B. L. van der Hoeven, J. Daemen, A. H. van den Meiracker, A. A. Kroon, M. W. de Haan, Marco Das, M. Bax, I. M. van der Meer, H. van Overhagen, B. J. H. van den Born, P. M. van Brussel, P. H. M. van der Valk, P. J. H. Smak Gregoor, M. MeuwissenM. E. R. Gomes, T. Oude Ophuis, E. Troe, W. A. L. Tonino, C. J. A. M. Konings, P. A. M. de Vries, A. van Balen, J. E. Heeg, J. J. J. Smit, A. Elvan, R. Steggerda, S. M. L. Niamut, J. O. J. Peels, J. B. R. M. de Swart, A. J. Wardeh, J. H. M. Groeneveld, E. van der Linden, M. H. Hemmelder, R. Folkeringa, M. G. Stoel, G. D. Kant, J. P. R. Herrman, S. van Wissen, J. Deinum, S. W. Westra, W. R. M. Aengevaeren, K. J. Parlevliet, A. Schramm, G. A. J. Jessurun, B. J. W. M. Rensing, M. H. M. Winkens, T. K. A. Wierema, E. Santegoets, E. Lipsic, E. Houwerzijl, M. Kater, C. P. Allaart, A. Nap, M. L. Bots^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background: Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands.Methods: The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up.Results: Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (+/- 29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (+/- 18/13) mmHg. RDN was performed with different devices, with the Simplicity T catheter currently used most frequently.Conclusion: Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.

Original language	English
Pages (from-to)	5-15
Journal	Netherlands Journal of Medicine
Volume	74
Issue number	1
Publication status	Published - Jan 2016

Keywords

Blood pressure
cardiovascular disease
hypertension
kidney function
renal denervation

Cite this

Sanders, M. F., Blankestijn, P. J., Voskuil, M., Spiering, W., Vonken, E. J., Rotmans, J. I., van der Hoeven, B. L., Daemen, J., van den Meiracker, A. H., Kroon, A. A., de Haan, M. W., Das, M., Bax, M., van der Meer, I. M., van Overhagen, H., van den Born, B. J. H., van Brussel, P. M., van der Valk, P. H. M., Gregoor, P. J. H. S., ... Bots, M. L. (2016). Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry. Netherlands Journal of Medicine, 74(1), 5-15.

@article{cf98e1936cdb4f9c9f8ffb938dd18f0a,

title = "Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry",

abstract = "Background: Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands.Methods: The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up.Results: Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (+/- 29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (+/- 18/13) mmHg. RDN was performed with different devices, with the Simplicity T catheter currently used most frequently.Conclusion: Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.",

keywords = "Blood pressure, cardiovascular disease, hypertension, kidney function, renal denervation",

author = "Sanders, {M. F.} and Blankestijn, {P. J.} and M. Voskuil and W. Spiering and Vonken, {E. J.} and Rotmans, {J. I.} and {van der Hoeven}, {B. L.} and J. Daemen and {van den Meiracker}, {A. H.} and Kroon, {A. A.} and {de Haan}, {M. W.} and Marco Das and M. Bax and {van der Meer}, {I. M.} and {van Overhagen}, H. and {van den Born}, {B. J. H.} and {van Brussel}, {P. M.} and {van der Valk}, {P. H. M.} and Gregoor, {P. J. H. Smak} and M. Meuwissen and Gomes, {M. E. R.} and Ophuis, {T. Oude} and E. Troe and Tonino, {W. A. L.} and Konings, {C. J. A. M.} and {de Vries}, {P. A. M.} and {van Balen}, A. and Heeg, {J. E.} and Smit, {J. J. J.} and A. Elvan and R. Steggerda and Niamut, {S. M. L.} and Peels, {J. O. J.} and {de Swart}, {J. B. R. M.} and Wardeh, {A. J.} and Groeneveld, {J. H. M.} and {van der Linden}, E. and Hemmelder, {M. H.} and R. Folkeringa and Stoel, {M. G.} and Kant, {G. D.} and Herrman, {J. P. R.} and {van Wissen}, S. and J. Deinum and Westra, {S. W.} and Aengevaeren, {W. R. M.} and Parlevliet, {K. J.} and A. Schramm and Jessurun, {G. A. J.} and Rensing, {B. J. W. M.} and Winkens, {M. H. M.} and Wierema, {T. K. A.} and E. Santegoets and E. Lipsic and E. Houwerzijl and M. Kater and Allaart, {C. P.} and A. Nap and Bots, {M. L.}",

year = "2016",

month = jan,

language = "English",

volume = "74",

pages = "5--15",

journal = "Netherlands Journal of Medicine",

issn = "0300-2977",

publisher = "Van Zuiden Communications",

number = "1",

}

Sanders, MF, Blankestijn, PJ, Voskuil, M, Spiering, W, Vonken, EJ, Rotmans, JI, van der Hoeven, BL, Daemen, J, van den Meiracker, AH, Kroon, AA , de Haan, MW, Das, M, Bax, M, van der Meer, IM, van Overhagen, H, van den Born, BJH, van Brussel, PM, van der Valk, PHM, Gregoor, PJHS, Meuwissen, M, Gomes, MER, Ophuis, TO, Troe, E, Tonino, WAL, Konings, CJAM, de Vries, PAM, van Balen, A, Heeg, JE, Smit, JJJ, Elvan, A, Steggerda, R, Niamut, SML, Peels, JOJ, de Swart, JBRM, Wardeh, AJ, Groeneveld, JHM, van der Linden, E, Hemmelder, MH, Folkeringa, R, Stoel, MG, Kant, GD, Herrman, JPR, van Wissen, S, Deinum, J, Westra, SW, Aengevaeren, WRM, Parlevliet, KJ, Schramm, A, Jessurun, GAJ, Rensing, BJWM, Winkens, MHM, Wierema, TKA, Santegoets, E, Lipsic, E, Houwerzijl, E, Kater, M, Allaart, CP, Nap, A & Bots, ML 2016, 'Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry', Netherlands Journal of Medicine, vol. 74, no. 1, pp. 5-15.

TY - JOUR

T1 - Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry

AU - Sanders, M. F.

AU - Blankestijn, P. J.

AU - Voskuil, M.

AU - Spiering, W.

AU - Vonken, E. J.

AU - Rotmans, J. I.

AU - van der Hoeven, B. L.

AU - Daemen, J.

AU - van den Meiracker, A. H.

AU - Kroon, A. A.

AU - de Haan, M. W.

AU - Das, Marco

AU - Bax, M.

AU - van der Meer, I. M.

AU - van Overhagen, H.

AU - van den Born, B. J. H.

AU - van Brussel, P. M.

AU - van der Valk, P. H. M.

AU - Gregoor, P. J. H. Smak

AU - Meuwissen, M.

AU - Gomes, M. E. R.

AU - Ophuis, T. Oude

AU - Troe, E.

AU - Tonino, W. A. L.

AU - Konings, C. J. A. M.

AU - de Vries, P. A. M.

AU - van Balen, A.

AU - Heeg, J. E.

AU - Smit, J. J. J.

AU - Elvan, A.

AU - Steggerda, R.

AU - Niamut, S. M. L.

AU - Peels, J. O. J.

AU - de Swart, J. B. R. M.

AU - Wardeh, A. J.

AU - Groeneveld, J. H. M.

AU - van der Linden, E.

AU - Hemmelder, M. H.

AU - Folkeringa, R.

AU - Stoel, M. G.

AU - Kant, G. D.

AU - Herrman, J. P. R.

AU - van Wissen, S.

AU - Deinum, J.

AU - Westra, S. W.

AU - Aengevaeren, W. R. M.

AU - Parlevliet, K. J.

AU - Schramm, A.

AU - Jessurun, G. A. J.

AU - Rensing, B. J. W. M.

AU - Winkens, M. H. M.

AU - Wierema, T. K. A.

AU - Santegoets, E.

AU - Lipsic, E.

AU - Houwerzijl, E.

AU - Kater, M.

AU - Allaart, C. P.

AU - Nap, A.

AU - Bots, M. L.

PY - 2016/1

Y1 - 2016/1

N2 - Background: Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands.Methods: The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up.Results: Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (+/- 29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (+/- 18/13) mmHg. RDN was performed with different devices, with the Simplicity T catheter currently used most frequently.Conclusion: Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.

AB - Background: Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands.Methods: The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up.Results: Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (+/- 29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (+/- 18/13) mmHg. RDN was performed with different devices, with the Simplicity T catheter currently used most frequently.Conclusion: Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.

KW - Blood pressure

KW - cardiovascular disease

KW - hypertension

KW - kidney function

KW - renal denervation

M3 - Article

SN - 0300-2977

VL - 74

SP - 5

EP - 15

JO - Netherlands Journal of Medicine

JF - Netherlands Journal of Medicine

IS - 1

ER -