Renal Denervation in Patients With Refractory Hypertension

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT00483808

First received: June 5, 2007

Last updated: April 18, 2013

Last verified: April 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Hypertension	Device: Ardian Symplicity™ Catheter	Phase 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:

To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	June 2007
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Denervation Renal denervation using the Symplicty Catheter	Device: Ardian Symplicity™ Catheter Renal denervation using the Symplicity Catheter

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483808

Locations

Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Poland
John Paul II Hospital
Krakow, Poland

Sponsors and Collaborators

Medtronic Vascular

Investigators

Principal Investigator:	Henry Krum, MBBS,PhD	The Alfred Hospital and Monash University, Melbourne, VIC, Australia
Principal Investigator:	Robert Whitbourn, MBBS, FRACP	St. Vincent's Hospital, Fitzroy, VIC, Australia

More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Witkowski A, Prejbisz A, Florczak E, K?dziela J, ?liwi?ski P, Biele? P, Micha?owska I, Kabat M, Warcho? 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. Epub 2011 Aug 15.

Hering D, Esler MD, Krum H, Mahfoud F, Böhm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44.

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. 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. Epub 2009 Mar 28.

Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT00483808 History of Changes
Other Study ID Numbers:	TP-015 & TP-038
Study First Received:	June 5, 2007
Last Updated:	April 18, 2013
Health Authority:	Australia: Department of Health and Aging Therapeutic Goods Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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