NCT00483808

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_1 hypertension

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

5.9 years

First QC Date

June 5, 2007

Last Update Submit

November 1, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • To provide confirmation that renal denervation is safe and feasible.

    3 years

Secondary Outcomes (1)

  • Evidence of renal denervation; indication of physiologic response; assessment of device performance.

    3 years

Study Arms (1)

Denervation

EXPERIMENTAL

Renal denervation using the Symplicty Catheter

Device: Ardian Symplicity™ Catheter

Interventions

Ardian Symplicity™ CatheterDEVICE

Renal denervation using the Symplicity Catheter

Denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

John Paul II Hospital

Krakow, Poland

Location

Related Publications (7)

  • 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.

    PMID: 28611687DERIVED

  • 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.

    PMID: 24210779DERIVED

  • 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.

    PMID: 22457244DERIVED

  • 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.

    PMID: 21844482DERIVED

  • 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.

    PMID: 21714604DERIVED

  • 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.

    PMID: 19822798DERIVED

  • 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.

    PMID: 19332353DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 7, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

PL(1)AU(2)