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

• ClinicalTrials.gov Identifier: NCT00888433
• Recruitment Status: Completed
• First Posted: April 27, 2009
• Results First Posted: February 24, 2014
• Last Update Posted: May 20, 2015
• Sponsor: Medtronic Vascular
• Information provided by (Responsible Party): Medtronic Vascular

Tracking Information

• First Submitted Date: April 24, 2009
• First Posted Date: April 27, 2009
• Results First Submitted Date: September 13, 2013
• Results First Posted Date: February 24, 2014
• Last Update Posted Date: May 20, 2015
• Study Start Date: June 2009
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2014)

Office Systolic Blood Pressure Reduction [ Time Frame: Baseline to 6 months ]

The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
• Official Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
• Brief Summary: An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Uncontrolled Hypertension

Intervention

Device: Renal Denervation (Symplicity® Renal Denervation System)

Catheter-based renal denervation

Study Arms

• Experimental: Renal Denervation
  Renal Denervation and maintenance of anti-hypertensive medications
  Intervention: Device: Renal Denervation (Symplicity® Renal Denervation System)
• No Intervention: Control
  Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

Publications *

• 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. 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). pii: e002343. doi: 10.1161/JAHA.115.002343.
• Esler MD, Böhm 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, Böhm 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. Erratum in: Circulation. 2014 May 20;129(20):e502.
• 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. 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, 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. 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, 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. doi: 10.1097/HJH.0b013e328344db3a.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2010): 106
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, France, Germany, Latvia, Poland, Spain, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT00888433
• Other Study ID Numbers: TP-058
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medtronic Vascular
• Study Sponsor: Medtronic Vascular
• Collaborators: Not Provided

Investigators

• Principal Investigator: Murray Esler, MBBS; The Baker IDI Heart & Diabetes Institute

• PRS Account: Medtronic Vascular
• Verification Date: May 2015