Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
NCT ID: NCT00888433
Last Updated: 2015-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2009-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications
Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
Control
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
No interventions assigned to this group
Interventions
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Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
Eligibility Criteria
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Inclusion Criteria
* on 3 or more antihypertensive medications
* \>= 18 and =\< 85 years of age.
Exclusion Criteria
* eGFR \< 45mL/min
* MI, angina, CVA within 6 months
* Type 1 diabetes
* ICD or pacemaker, or any other metallic implant not compatible with MRI
* others
18 Years
85 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Murray Esler, MBBS
Role: PRINCIPAL_INVESTIGATOR
The Baker IDI Heart & Diabetes Institute
Locations
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Alfred Hospital
Melbourne, , Australia
Vienna General Hospital
Vienna, , Austria
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Hopital Européen Georges Pompidou
Paris, , France
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Universität zu Köln
Cologne, , Germany
Universitaetsklinikum Dusseldorf
Düsseldorf, , Germany
University of Erlangen at Nuremburg
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
CardioVascular Center Frankfurt
Frankfurt, , Germany
Universitatskliniken des Saarlandes
Homburg, , Germany
University of Leipzig - Herzzentrum
Leipzig, , Germany
Universitatsklinikum Schleswig-Holstein, Luebeck Campus
Leubeck, , Germany
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Samodzielna Pracownia Hemodynamiczna
Warsaw, , Poland
Hospital 12 de Octubre
Madrid, , Spain
Universitaatsspital Zurich
Zurich, , Switzerland
Kent and Canterbury Hospital
Canterbury, , United Kingdom
University of Glasgow
Glasgow, , United Kingdom
Barts and the London School of Dentistry & Medicine
London, , United Kingdom
Countries
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References
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Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
Eikelis N, Hering D, Marusic P, Duval J, Hammond LJ, Walton AS, Lambert EA, Esler MD, Lambert GW, Schlaich MP. The Effect of Renal Denervation on Plasma Adipokine Profile in Patients with Treatment Resistant Hypertension. Front Physiol. 2017 May 30;8:369. doi: 10.3389/fphys.2017.00369. eCollection 2017.
Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
Esler MD, Bohm M, Sievert H, Rump CL, Schmieder RE, Krum H, Mahfoud F, Schlaich MP. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J. 2014 Jul;35(26):1752-9. doi: 10.1093/eurheartj/ehu209. Epub 2014 Jun 4.
Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Bohm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013 Jul 9;128(2):132-40. doi: 10.1161/CIRCULATIONAHA.112.000949. Epub 2013 Jun 18.
Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880.
Ukena C, Mahfoud F, Kindermann I, Barth C, Lenski M, Kindermann M, Brandt MC, Hoppe UC, Krum H, Esler M, Sobotka PA, Bohm M. Cardiorespiratory response to exercise after renal sympathetic denervation in patients with resistant hypertension. J Am Coll Cardiol. 2011 Sep 6;58(11):1176-82. doi: 10.1016/j.jacc.2011.05.036.
Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25.
Schlaich MP, Straznicky N, Grima M, Ika-Sari C, Dawood T, Mahfoud F, Lambert E, Chopra R, Socratous F, Hennebry S, Eikelis N, Bohm M, Krum H, Lambert G, Esler MD, Sobotka PA. Renal denervation: a potential new treatment modality for polycystic ovary syndrome? J Hypertens. 2011 May;29(5):991-6. doi: 10.1097/HJH.0b013e328344db3a.
Related Links
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Related Info
Other Identifiers
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TP-058
Identifier Type: -
Identifier Source: org_study_id
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