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

May 4, 2015 updated by: Medtronic Vascular
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Alfred Hospital
  • Austria
      • Vienna, Austria
        • Vienna General Hospital
  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint Luc
  • France
      • Paris, France
        • Hopital Europeen Georges Pompidou
  • Germany
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Cologne, Germany
        • Universität zu Köln
      • Dusseldorf, Germany
        • Universitaetsklinikum Dusseldorf
      • Erlangen, Germany
        • University of Erlangen at Nuremburg
      • Essen, Germany
        • Universitaetsklinikum Essen
      • Frankfurt, Germany
        • Cardiovascular Center Frankfurt
      • Homburg, Germany
        • Universitätskliniken des Saarlandes
      • Leipzig, Germany
        • University of Leipzig - Herzzentrum
      • Leubeck, Germany
        • Universitatsklinikum Schleswig-Holstein, Luebeck Campus
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
  • Poland
      • Warsaw, Poland
        • Samodzielna Pracownia Hemodynamiczna
  • Spain
      • Madrid, Spain
        • Hospital 12 de Octubre
  • Switzerland
      • Zurich, Switzerland
        • Universitaatsspital Zurich
  • United Kingdom
      • Canterbury, United Kingdom
        • Kent and Canterbury Hospital
      • Glasgow, United Kingdom
        • University of Glasgow
      • London, United Kingdom
        • Barts and the London School of Dentistry & Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Office Systolic Blood Pressure Reduction
Time Frame: Baseline to 6 months
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Murray Esler, MBBS, The Baker IDI Heart & Diabetes Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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