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.
| Errataetall: |
CommentIn: J Hypertens. 2016 Aug;34(8):1505-6. - PMID 27356001 |
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| Medienart: |
E-Artikel |
| 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 vom: 15. Aug., Seite 1639-47 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mathiassen, Ole N [VerfasserIn] |
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| Links: |
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| Themen: |
Antihypertensive Agents |
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| Anmerkungen: |
Date Completed 12.09.2017 Date Revised 02.12.2018 published: Print CommentIn: J Hypertens. 2016 Aug;34(8):1505-6. - PMID 27356001 Citation Status MEDLINE |
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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): |
NLM260772569 |
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| 100 | 1 | |a Mathiassen, Ole N |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial |
| 264 | 1 | |c 2016 | |
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| 500 | |a Date Revised 02.12.2018 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: J Hypertens. 2016 Aug;34(8):1505-6. - PMID 27356001 | ||
| 500 | |a Citation Status MEDLINE | ||
| 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antihypertensive Agents |2 NLM | |
| 700 | 1 | |a Vase, Henrik |e verfasserin |4 aut | |
| 700 | 1 | |a Bech, Jesper N |e verfasserin |4 aut | |
| 700 | 1 | |a Christensen, Kent L |e verfasserin |4 aut | |
| 700 | 1 | |a Buus, Niels H |e verfasserin |4 aut | |
| 700 | 1 | |a Schroeder, Anne P |e verfasserin |4 aut | |
| 700 | 1 | |a Lederballe, Ole |e verfasserin |4 aut | |
| 700 | 1 | |a Rickers, Hans |e verfasserin |4 aut | |
| 700 | 1 | |a Kampmann, Ulla |e verfasserin |4 aut | |
| 700 | 1 | |a Poulsen, Per L |e verfasserin |4 aut | |
| 700 | 1 | |a Hansen, Klavs W |e verfasserin |4 aut | |
| 700 | 1 | |a Btker, Hans E |e verfasserin |4 aut | |
| 700 | 1 | |a Peters, Christian D |e verfasserin |4 aut | |
| 700 | 1 | |a Engholm, Morten |e verfasserin |4 aut | |
| 700 | 1 | |a Bertelsen, Jannik B |e verfasserin |4 aut | |
| 700 | 1 | |a Lassen, Jens F |e verfasserin |4 aut | |
| 700 | 1 | |a Langfeldt, Sten |e verfasserin |4 aut | |
| 700 | 1 | |a Andersen, Gratien |e verfasserin |4 aut | |
| 700 | 1 | |a Pedersen, Erling B |e verfasserin |4 aut | |
| 700 | 1 | |a Kaltoft, Anne |e verfasserin |4 aut | |
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