Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

Ole N Mathiassen; Henrik Vase; Jesper N Bech; Kent Lodberg Christensen; Niels H Buus; Anne P Schroeder; Ole Lederballe; Hans Rickers; Ulla Kampmann; Per L Poulsen; Klavs W Hansen; Hans Erik Bøtker; Christian Daugaard Peters; Morten Engholm; Jannik B Bertelsen; Jens F Lassen; Sten Langfeldt; Gratien Andersen; Erling B Pedersen; Anne Kaltoft

doi:10.1097/HJH.0000000000000977

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

Ole N Mathiassen, Henrik Vase, Jesper N Bech, Kent Lodberg Christensen, Niels H Buus, Anne P Schroeder, Ole Lederballe, Hans Rickers, Ulla Kampmann, Per L Poulsen, Klavs W Hansen, Hans Erik Bøtker, Christian Daugaard Peters, Morten Engholm, Jannik B Bertelsen, Jens F Lassen, Sten Langfeldt, Gratien Andersen, Erling B Pedersen, Anne Kaltoft

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

114 Citations (Scopus)

350 Downloads (Pure)

Abstract

Background: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. Method: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). Results: We randomized 69 patients with treatment-resistant hypertension to RDN (n=36) or SHAM (n=33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159±12mmHg (RDN) and 159±14mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2±18.8mmHg (RDN) vs. -6.0±13.5mmHg (SHAM)] and at 6 months [-6.1±18.9mmHg (RDN) vs. -4.3±15.1mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8±2.7 (RDN) vs. 7.0±2.5 (SHAM)]. RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Conclusion: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Original language	English
Journal	Journal of Hypertension
Volume	34
Issue	8
Pages (from-to)	1639-1647
Number of pages	9
ISSN	0263-6352
DOIs	https://doi.org/10.1097/HJH.0000000000000977
Publication status	Published - Aug 2016

Keywords

SHAM procedure
ambulatory blood pressure measurement
randomized controlled trial
renal denervation
treatment-resistant hypertension

Access to Document

10.1097/HJH.0000000000000977

Mathiassen Renal denervation in treatment-resistant essential hypertension A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trialFinal published version, 719 KBLicence: Unspecified

Cite this

Mathiassen, O. N., Vase, H., Bech, J. N., Christensen, K. L., Buus, N. H., Schroeder, A. P., Lederballe, O., Rickers, H., Kampmann, U., Poulsen, P. L., Hansen, K. W., Bøtker, H. E., Peters, C. D., Engholm, M., Bertelsen, J. B., Lassen, J. F., Langfeldt, S., Andersen, G., Pedersen, E. B., & Kaltoft, A. (2016). Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. Journal of Hypertension, 34(8), 1639-1647. https://doi.org/10.1097/HJH.0000000000000977

@article{4b1d28522bd94dcdb2755e7b4efde781,

title = "Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial",

abstract = "Background: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. Method: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). Results: We randomized 69 patients with treatment-resistant hypertension to RDN (n=36) or SHAM (n=33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159±12mmHg (RDN) and 159±14mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2±18.8mmHg (RDN) vs. -6.0±13.5mmHg (SHAM)] and at 6 months [-6.1±18.9mmHg (RDN) vs. -4.3±15.1mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8±2.7 (RDN) vs. 7.0±2.5 (SHAM)]. RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Conclusion: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.",

keywords = "SHAM procedure, ambulatory blood pressure measurement, randomized controlled trial, renal denervation, treatment-resistant hypertension",

author = "Mathiassen, {Ole N} and Henrik Vase and Bech, {Jesper N} and Christensen, {Kent Lodberg} and Buus, {Niels H} and Schroeder, {Anne P} and Ole Lederballe and Hans Rickers and Ulla Kampmann and Poulsen, {Per L} and Hansen, {Klavs W} and B{\o}tker, {Hans Erik} and Peters, {Christian Daugaard} and Morten Engholm and Bertelsen, {Jannik B} and Lassen, {Jens F} and Sten Langfeldt and Gratien Andersen and Pedersen, {Erling B} and Anne Kaltoft",

year = "2016",

month = aug,

doi = "10.1097/HJH.0000000000000977",

language = "English",

volume = "34",

pages = "1639--1647",

journal = "Journal of Hypertension",

issn = "0263-6352",

publisher = "Lippincott Williams and Wilkins",

number = "8",

}

Mathiassen, ON, Vase, H, Bech, JN, Christensen, KL, Buus, NH, Schroeder, AP, Lederballe, O, Rickers, H, Kampmann, U , Poulsen, PL , Hansen, KW , Bøtker, HE , Peters, CD , Engholm, M , Bertelsen, JB, Lassen, JF, Langfeldt, S, Andersen, G, Pedersen, EB & Kaltoft, A 2016, 'Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial', Journal of Hypertension, vol. 34, no. 8, pp. 1639-1647. https://doi.org/10.1097/HJH.0000000000000977

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. / Mathiassen, Ole N; Vase, Henrik; Bech, Jesper N et al.
In: Journal of Hypertension, Vol. 34, No. 8, 08.2016, p. 1639-1647.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

AU - Mathiassen, Ole N

AU - Vase, Henrik

AU - Bech, Jesper N

AU - Christensen, Kent Lodberg

AU - Buus, Niels H

AU - Schroeder, Anne P

AU - Lederballe, Ole

AU - Rickers, Hans

AU - Kampmann, Ulla

AU - Poulsen, Per L

AU - Hansen, Klavs W

AU - Bøtker, Hans Erik

AU - Peters, Christian Daugaard

AU - Engholm, Morten

AU - Bertelsen, Jannik B

AU - Lassen, Jens F

AU - Langfeldt, Sten

AU - Andersen, Gratien

AU - Pedersen, Erling B

AU - Kaltoft, Anne

PY - 2016/8

Y1 - 2016/8

N2 - Background: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. Method: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). Results: We randomized 69 patients with treatment-resistant hypertension to RDN (n=36) or SHAM (n=33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159±12mmHg (RDN) and 159±14mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2±18.8mmHg (RDN) vs. -6.0±13.5mmHg (SHAM)] and at 6 months [-6.1±18.9mmHg (RDN) vs. -4.3±15.1mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8±2.7 (RDN) vs. 7.0±2.5 (SHAM)]. RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Conclusion: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

AB - Background: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. Method: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). Results: We randomized 69 patients with treatment-resistant hypertension to RDN (n=36) or SHAM (n=33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159±12mmHg (RDN) and 159±14mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2±18.8mmHg (RDN) vs. -6.0±13.5mmHg (SHAM)] and at 6 months [-6.1±18.9mmHg (RDN) vs. -4.3±15.1mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8±2.7 (RDN) vs. 7.0±2.5 (SHAM)]. RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Conclusion: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

KW - SHAM procedure

KW - ambulatory blood pressure measurement

KW - randomized controlled trial

KW - renal denervation

KW - treatment-resistant hypertension

UR - http://www.scopus.com/inward/record.url?scp=84970024022&partnerID=8YFLogxK

U2 - 10.1097/HJH.0000000000000977

DO - 10.1097/HJH.0000000000000977

M3 - Journal article

C2 - 27228432

SN - 0263-6352

VL - 34

SP - 1639

EP - 1647

JO - Journal of Hypertension

JF - Journal of Hypertension

IS - 8

ER -

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this