Renal Denervation Hypertension After Stroke (REHEARSE)

January 26, 2021 updated by: Hanne Christensen, Bispebjerg Hospital

Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension

It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention.

This pilot study will examine the effect of renal nerve denervation in patients with treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24 hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6 and 12 months after the procedure.

Study Overview

Status

Terminated

Conditions

Detailed Description

Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in patients with treatment resistant hypertension.

The hypothesis is that RDN is able to reduce the blood pressure in patients with previous stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke.

Aim of study:

  1. To validate the reduction in blood pressure after RND in patients with stroke and treatment resistant hypertension compared to the results achieved in patients only with essential hypertension
  2. To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient)
  3. To describe the effect of RND in the development of changes in the white matter over time

Study Type

Observational

Enrollment (Anticipated)

25

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

  • Denmark
    • Region H
      • Copenhagen, Region H, Denmark, 2400
        • Bispebjerg Hospital, Department of neurology

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

Non-Probability Sample

Study Population

Patients in the study population must be 18+ years old and have a clinical verified stroke within the last year and treatment resistant hypertension at 150 mm Hg or higher systolic at consultation. The patients Modified Ranking Scale must be between 0-2.

Description

Inclusion Criteria:

  • 18+ years old
  • Clinical verified stroke within the last year
  • Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation
  • Modified Ranking between 0-2

Exclusion Criteria:

  • Lack of informed consent
  • Renal artery anatomy, which prevents the procedure
  • Reno vascular disease
  • Pacemaker
  • Haemodynamic vascular occlusion or valve disease
  • Pregnancy or women in the childbearing age
  • Secondary hypertension
  • Mean systolic blood pressure over 180 mm Hg

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
24 hour blood pressure
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Bispebjerg Hospital

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hanne Christensen, MD,Ph.D,DMSci, Bispebjerg Hospital - Department of Neurology

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

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2012-102

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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