Renal Denervation in Patients With Refractory Hypertension
NCT ID: NCT00483808
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2007-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Denervation
Renal denervation using the Symplicty Catheter
Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
Interventions
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Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Henry Krum, MBBS,PhD
Role: PRINCIPAL_INVESTIGATOR
The Alfred Hospital and Monash University, Melbourne, VIC, Australia
Robert Whitbourn, MBBS, FRACP
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital, Fitzroy, VIC, Australia
Locations
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St. Vincent's Hospital
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
John Paul II Hospital
Krakow, , Poland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TP-015 & TP-038
Identifier Type: -
Identifier Source: org_study_id