NCT00664638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

9 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

April 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
5 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

5.1 years

First QC Date

April 21, 2008

Last Update Submit

November 1, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension.

    3 years

Secondary Outcomes (1)

  • To document the physiologic effects of renal denervation in patients with refractory hypertension.

    3 years

Interventions

Symplicty(TM) Catheter SystemDEVICE

Renal denervation using the Symplicity Catheter System

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 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

You may not qualify if:

  • hemodynamically or anatomically significant renal artery stenosis
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

St. Elisabeth Hospital

Bochum, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Location

University of Erlangen at Nuremburg

Erlangen, Germany

Location

CardioVascular Center Frankfurt, Sankt Katharinen

Frankfurt, Germany

Location

Clinical Trial Center North

Hamburg, Germany

Location

Universitatskliniken des Saarlandes

Homburg, Germany

Location

University of Leipzig - Herzzentrum

Leipzig, Germany

Location

Related Publications (4)

  • 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

  • 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.

    PMID: 23780578DERIVED

  • 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.

    PMID: 21518978DERIVED

  • 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, PhD

    Monash University and The Alfred Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

DE(9)