Clinical trial NCT00483808: Renal Denervation in Patients With Refractory Hypertension
Official title: Renal Denervation in Patients With Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 160 mmHg or greater.
* receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
* agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
* competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* renal arterial abnormalities
* end stage renal disease requiring dialysis or renal transplant
* serum Cr \> 3, or calculated GFR \< 45 ml/min
* has experienced MI, unstable angina pectoris, or CVA with 6 months
* others

Primary outcomes:
measure: To provide confirmation that renal denervation is safe and feasible.
timeFrame: 3 years
Secondary outcomes:
measure: Evidence of renal denervation; indication of physiologic response; assessment of device performance.
timeFrame: 3 years
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Krakow
country: Poland
facility: John Paul II Hospital
Study officials:
affiliation: The Alfred Hospital and Monash University, Melbourne, VIC, Australia
name: Henry Krum, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's Hospital, Fitzroy, VIC, Australia
name: Robert Whitbourn, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.
citation: Witkowski A, Prejbisz A, Florczak E, Kadziela J, Sliwinski P, Bielen P, Michalowska I, Kabat M, Warchol E, Januszewicz M, Narkiewicz K, Somers VK, Sobotka PA, Januszewicz A. Effects of renal sympathetic denervation on blood pressure, sleep apnea course, and glycemic control in patients with resistant hypertension and sleep apnea. Hypertension. 2011 Oct;58(4):559-65. doi: 10.1161/HYPERTENSIONAHA.111.173799. Epub 2011 Aug 15.
citation: Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.
citation: Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
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.