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Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial

Summary Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre,... Full description

Journal Title: The Lancet (British edition) 2010, Vol.376 (9756), p.1903-1909
Main Author: Esler, Murray D
Other Authors: Krum, Henry , Sobotka, Paul A , Schlaich, Markus P , Schmieder, Roland E , Böhm, Michael
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial
format: Article
creator:
  • Esler, Murray D
  • Krum, Henry
  • Sobotka, Paul A
  • Schlaich, Markus P
  • Schmieder, Roland E
  • Böhm, Michael
subjects:
  • Abridged Index Medicus
  • Aged
  • Antihypertensive Agents - therapeutic use
  • Arterial hypertension. Arterial hypotension
  • Biological and medical sciences
  • Blood and lymphatic vessels
  • Blood pressure
  • Blood Pressure Monitoring, Ambulatory
  • Cardiology. Vascular system
  • Care and treatment
  • Compliance
  • Control
  • Denervation
  • Diabetes
  • Disease
  • Essential hypertension
  • Female
  • General aspects
  • Humans
  • Hypertension
  • Hypertension - diagnosis
  • Hypertension - drug therapy
  • Hypertension - surgery
  • Internal Medicine
  • Kidney - innervation
  • Male
  • Medical imaging
  • Medical sciences
  • Middle Aged
  • Mortality
  • Physiological aspects
  • Prospective Studies
  • Radio frequency
  • Sympathectomy
  • Veins & arteries
ispartof: The Lancet (British edition), 2010, Vol.376 (9756), p.1903-1909
description: Summary Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov , number NCT00888433. Findings 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
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titleRenal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial
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creatorEsler, Murray D ; Krum, Henry ; Sobotka, Paul A ; Schlaich, Markus P ; Schmieder, Roland E ; Böhm, Michael
creatorcontribEsler, Murray D ; Krum, Henry ; Sobotka, Paul A ; Schlaich, Markus P ; Schmieder, Roland E ; Böhm, Michael ; Symplicity HTN-2 Investigators
descriptionSummary Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov , number NCT00888433. Findings 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ from baseline in the control group (change of 1/0 mm Hg [21/10], baseline of 178/97 mm Hg, p=0·77 systolic and p=0·83 diastolic). Between-group differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84%) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35%) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients. Funding Ardian.
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subjectAbridged Index Medicus ; Aged ; Antihypertensive Agents - therapeutic use ; Arterial hypertension. Arterial hypotension ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood pressure ; Blood Pressure Monitoring, Ambulatory ; Cardiology. Vascular system ; Care and treatment ; Compliance ; Control ; Denervation ; Diabetes ; Disease ; Essential hypertension ; Female ; General aspects ; Humans ; Hypertension ; Hypertension - diagnosis ; Hypertension - drug therapy ; Hypertension - surgery ; Internal Medicine ; Kidney - innervation ; Male ; Medical imaging ; Medical sciences ; Middle Aged ; Mortality ; Physiological aspects ; Prospective Studies ; Radio frequency ; Sympathectomy ; Veins & arteries
ispartofThe Lancet (British edition), 2010, Vol.376 (9756), p.1903-1909
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descriptionSummary Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov , number NCT00888433. Findings 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ from baseline in the control group (change of 1/0 mm Hg [21/10], baseline of 178/97 mm Hg, p=0·77 systolic and p=0·83 diastolic). Between-group differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84%) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35%) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients. Funding Ardian.
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titleRenal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial
authorEsler, Murray D ; Krum, Henry ; Sobotka, Paul A ; Schlaich, Markus P ; Schmieder, Roland E ; Böhm, Michael
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7Blood Pressure Monitoring, Ambulatory
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abstractSummary Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov , number NCT00888433. Findings 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ from baseline in the control group (change of 1/0 mm Hg [21/10], baseline of 178/97 mm Hg, p=0·77 systolic and p=0·83 diastolic). Between-group differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84%) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35%) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients. Funding Ardian.
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pmid21093036
doi10.1016/S0140-6736(10)62039-9