Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial
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 145 mmHg 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 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [−6.2 ± 18.8 mmHg (RDN) vs. −6.0 ± 13.5 mmHg (SHAM)] and at 6 months [−6.1 ± 18.9 mmHg (RDN) vs. −4.3 ± 15.1 mmHg (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..
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:34 |
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| Enthalten in: |
Journal of hypertension - 34(2016), 8, Seite 1639-1647 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mathiassen, Ole N [VerfasserIn] |
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| Links: |
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| doi: |
10.1097/HJH.0000000000000977 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
OLC1977978029 |
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| 245 | 1 | 0 | |a Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial |
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| 520 | |a 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 145 mmHg 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 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [−6.2 ± 18.8 mmHg (RDN) vs. −6.0 ± 13.5 mmHg (SHAM)] and at 6 months [−6.1 ± 18.9 mmHg (RDN) vs. −4.3 ± 15.1 mmHg (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. | ||
| 540 | |a Nutzungsrecht: Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. | ||
| 700 | 1 | |a Vase, Henrik |4 oth | |
| 700 | 1 | |a Bech, Jesper N |4 oth | |
| 700 | 1 | |a Christensen, Kent L |4 oth | |
| 700 | 1 | |a Buus, Niels H |4 oth | |
| 700 | 1 | |a Schroeder, Anne P |4 oth | |
| 700 | 1 | |a Lederballe, Ole |4 oth | |
| 700 | 1 | |a Rickers, Hans |4 oth | |
| 700 | 1 | |a Kampmann, Ulla |4 oth | |
| 700 | 1 | |a Poulsen, Per L |4 oth | |
| 700 | 1 | |a Hansen, Klavs W |4 oth | |
| 700 | 1 | |a Btker, Hans E |4 oth | |
| 700 | 1 | |a Peters, Christian D |4 oth | |
| 700 | 1 | |a Engholm, Morten |4 oth | |
| 700 | 1 | |a Bertelsen, Jannik B |4 oth | |
| 700 | 1 | |a Lassen, Jens F |4 oth | |
| 700 | 1 | |a Langfeldt, Sten |4 oth | |
| 700 | 1 | |a Andersen, Gratien |4 oth | |
| 700 | 1 | |a Pedersen, Erling B |4 oth | |
| 700 | 1 | |a Kaltoft, Anne |4 oth | |
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