Renal Denervation in Patients With Refractory Hypertension
NCT ID: NCT00664638
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
NA
45 participants
INTERVENTIONAL
2008-04-30
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
TREATMENT
NONE
Interventions
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Symplicty(TM) Catheter System
Renal denervation using the Symplicity Catheter System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University and The Alfred Hospital
Locations
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Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
St. Elisabeth Hospital
Bochum, , Germany
Klinikum Coburg
Coburg, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
University of Erlangen at Nuremburg
Erlangen, , Germany
CardioVascular Center Frankfurt, Sankt Katharinen
Frankfurt, , Germany
Clinical Trial Center North
Hamburg, , Germany
Universitatskliniken des Saarlandes
Homburg, , Germany
University of Leipzig - Herzzentrum
Leipzig, , Germany
Countries
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References
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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.
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.
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.
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-037
Identifier Type: -
Identifier Source: org_study_id