Renal Denervation in Patients With Refractory Hypertension (HTN-1)

November 1, 2013 updated by: Medtronic Vascular
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Germany
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Bochum, Germany
        • St. Elisabeth Hospital
      • Coburg, Germany
        • Klinikum Coburg
      • Duesseldorf, Germany
        • Universitaetsklinikum Duesseldorf
      • Erlangen, Germany
        • University of Erlangen at Nuremburg
      • Frankfurt, Germany
        • CardioVascular Center Frankfurt, Sankt Katharinen
      • Hamburg, Germany
        • Clinical Trial Center North
      • Homburg, Germany
        • Universitätskliniken des Saarlandes
      • Leipzig, Germany
        • University of Leipzig - Herzzentrum

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >= 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

Exclusion Criteria:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To document the physiologic effects of renal denervation in patients with refractory hypertension.
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Henry Krum, PhD, Monash University and the Alfred Hospital

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

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

April 1, 2008

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-037

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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