Clinical trial NCT00664638: Renal Denervation in Patients With Refractory Hypertension
Official title: Renal Denervation in Patients With Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: To document the physiologic effects of renal denervation in patients with refractory hypertension.
timeFrame: 3 years
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bochum
country: Germany
facility: St. Elisabeth Hospital
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Erlangen
country: Germany
facility: University of Erlangen at Nuremburg
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt, Sankt Katharinen
city: Hamburg
country: Germany
facility: Clinical Trial Center North
city: Homburg
country: Germany
facility: Universitatskliniken des Saarlandes
city: Leipzig
country: Germany
facility: University of Leipzig - Herzzentrum
Study officials:
affiliation: Monash University and The Alfred Hospital
name: Henry Krum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krum H, Schlaich MP, Sobotka PA, Bohm 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.
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: 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: 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.