Renal Denervation in Patients With Refractory Hypertension (HTN-1)

• ClinicalTrials.gov Identifier: NCT00664638
• Recruitment Status: Completed
• First Posted: April 23, 2008
• Last Update Posted: November 5, 2013
• Sponsor: Medtronic Vascular
• Information provided by (Responsible Party): Medtronic Vascular

Tracking Information

• First Submitted Date: April 21, 2008
• First Posted Date: April 23, 2008
• Last Update Posted Date: November 5, 2013
• Study Start Date: April 2008
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 21, 2012): To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. [ Time Frame: 3 years ]
• Original Primary Outcome Measures (submitted: April 21, 2008): To provide confirmation that renal denervation is safe and feasible.
• Current Secondary Outcome Measures (submitted: September 21, 2012): To document the physiologic effects of renal denervation in patients with refractory hypertension. [ Time Frame: 3 years ]
• Original Secondary Outcome Measures (submitted: April 21, 2008): Indication of physiologic response and assessment of device performance
• 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 Refractory Hypertension
• Official Title: Renal Denervation in Patients With Refractory Hypertension
• Brief Summary: To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

Device: Symplicty(TM) Catheter System

Renal denervation using the Symplicity Catheter System

• Study Arms: Not Provided

Publications *

• Krum H, Schlaich MP, Sobotka PA, Böhm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7. Erratum in: Lancet. 2014 Feb 15;383(9917):602. Sobotka, Paul A [added].
• 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.
• 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.
• Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2010): 45
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• >= 18 years of age
• a systolic blood pressure of 160mmHg or more
• receiving and adhering to full doses of at least three antihypertensive drugs
• estimated glomerular filtration rate (eGFR) of ≥45mL/min
• agrees to have the study procedure(s) performed and additional procedures and evaluations
• is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

• hemodynamically or anatomically significant renal artery stenosis
• has a history or prior renal artery angioplasty
• has experienced MI, unstable angina pectoris, or CVA within 6 months
• has hemodynamically significant valvular heart disease
• has Type 1 diabetes
• has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
• requires respiratory support
• is pregnant, nursing, or planning to be pregnant
• has known, unresolved history of drug use or alcohol dependency.
• is currently enrolled in another investigational drug or device trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00664638
• Other Study ID Numbers: TP-037
• Has Data Monitoring Committee: No
• 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: Henry Krum, PhD; Monash University and The Alfred Hospital

• PRS Account: Medtronic Vascular
• Verification Date: November 2013