Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) - Full Text View

Purpose

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

Condition	Intervention
Uncontrolled Hypertension	Device: Renal Denervation (Symplicity® Catheter System)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:

Blood Pressure Reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	106
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2015
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Renal Denervation Renal Denervation and maintenance of anti-hypertensive medications	Device: Renal Denervation (Symplicity® Catheter System) Catheter-based renal denervation
No Intervention: Maintenance of Medications Maintenance of anti-hypertensive medications

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888433

Locations

Australia
Alfred Hospital
Melbourne, Australia
Austria
Vienna General Hospital
Vienna, Austria
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
France
Hopital Européen Georges Pompidou
Paris, France
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Universität zu Köln
Cologne, Germany
Universitaetsklinikum Dusseldorf
Dusseldorf, 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
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Poland
Samodzielna Pracownia Hemodynamiczna
Warsaw, Poland
Spain
Hospital 12 de Octubre
Madrid, Spain
Switzerland
Universitaatsspital Zurich
Zurich, Switzerland
United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
University of Glasgow
Glasgow, United Kingdom
Barts and the London School of Dentistry & Medicine
London, United Kingdom

Sponsors and Collaborators

Medtronic Vascular

Investigators

Principal Investigator:

Murray Esler, MBBS

The Baker IDI Heart & Diabetes Institute

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Esler MD, Krum H, Schlaich M, Schmieder RE, Böhm 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, Böhm 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.

Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Böhm 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. 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, Böhm 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.

Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Böhm 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. Epub 2010 Nov 17.

Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT00888433 History of Changes
Other Study ID Numbers:	TP-058
Study First Received:	April 24, 2009
Last Updated:	October 30, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Vascular:

hypertension
renal denervation
sympathetic nervous system
RDN

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013