Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension (RETREAT)

July 27, 2016 updated by: Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt

Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.

In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.

For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.

There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Study Type

Observational

Enrollment (Actual)

10

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
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
        • Cardiovascular Center Frankfurt

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.

Description

Inclusion Criteria:

  • Individual is ≥18 years old
  • Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
  • Systolic Office based blood pressure ≥140mmHg
  • Individual receives 3 or more antihypertensive drugs including one diuretic
  • Individual is willing to provide written informed consent to participate in this study

Exclusion Criteria:

  • Individual has hypertension secondary to an identifiable and treatable cause
  • Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
  • Individual is pregnant, nursing or planning to be pregnant
  • Renal artery abnormalities which may affect the procedure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Office Blood pressure measurement
Time Frame: up to1 year
up to1 year

Collaborators and Investigators

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

Sponsor

Cardiovascular Center Frankfurt

Investigators

  • Principal Investigator: Horst Sievert, M.D., Cardiovascular Center Frankfurt

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, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVC-001

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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