Clinical trial NCT00888433: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Official title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: hypertension
renal denervation
sympathetic nervous system
RDN
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Eligibility criteria: Inclusion Criteria:

* systolic blood pressure \>=160mmHg (\>=150 mmHg for type 2 diabetics);
* on 3 or more antihypertensive medications
* \>= 18 and =\< 85 years of age.

Exclusion Criteria:

* renal artery abnormalities
* 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

Primary outcomes:
measure: Office Systolic Blood Pressure Reduction
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Vienna
country: Austria
facility: Vienna General Hospital
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Cologne
country: Germany
facility: Universität zu Köln
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Erlangen
country: Germany
facility: University of Erlangen at Nuremburg
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
city: Homburg
country: Germany
facility: Universitatskliniken des Saarlandes
city: Leipzig
country: Germany
facility: University of Leipzig - Herzzentrum
city: Leubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Luebeck Campus
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Warsaw
country: Poland
facility: Samodzielna Pracownia Hemodynamiczna
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Zurich
country: Switzerland
facility: Universitaatsspital Zurich
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: London
country: United Kingdom
facility: Barts and the London School of Dentistry & Medicine
Study officials:
affiliation: The Baker IDI Heart & Diabetes Institute
name: Murray Esler, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.