Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00888433
First received: April 24, 2009
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Condition Intervention
Uncontrolled Hypertension
Device: Renal Denervation (Symplicity® Renal Denervation System)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Office Systolic Blood Pressure Reduction [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.


Enrollment: 106
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications
Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
No Intervention: Control
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
  • on 3 or more antihypertensive medications
  • >= 18 and =< 85 years of age.

Exclusion Criteria:

  • renal artery abnormalities
  • eGFR < 45mL/min
  • MI, angina, CVA within 6 months
  • Type 1 diabetes
  • ICD or pacemaker, or any other metallic implant not compatible with MRI
  • others
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888433

Locations
Australia
Alfred Hospital
Melbourne, Australia
Austria
Vienna General Hospital
Vienna, Austria
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
France
Hopital Européen Georges Pompidou
Paris, France
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Universität zu Köln
Cologne, Germany
Universitaetsklinikum Dusseldorf
Dusseldorf, Germany
University of Erlangen at Nuremburg
Erlangen, Germany
Universitaetsklinikum Essen
Essen, Germany
CardioVascular Center Frankfurt
Frankfurt, Germany
Universitatskliniken des Saarlandes
Homburg, Germany
University of Leipzig - Herzzentrum
Leipzig, Germany
Universitatsklinikum Schleswig-Holstein, Luebeck Campus
Leubeck, Germany
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Poland
Samodzielna Pracownia Hemodynamiczna
Warsaw, Poland
Spain
Hospital 12 de Octubre
Madrid, Spain
Switzerland
Universitaatsspital Zurich
Zurich, Switzerland
United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
University of Glasgow
Glasgow, United Kingdom
Barts and the London School of Dentistry & Medicine
London, United Kingdom
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Murray Esler, MBBS The Baker IDI Heart & Diabetes Institute
  More Information

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

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00888433     History of Changes
Other Study ID Numbers: TP-058
Study First Received: April 24, 2009
Results First Received: September 13, 2013
Last Updated: May 21, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Medtronic Vascular:
hypertension
renal denervation
sympathetic nervous system
RDN

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014