Renal Denervation Hypertension After Stroke (REHEARSE)

This study has been terminated.
(Based on results from SYMPLICITY HTN-3)
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Hanne Christensen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01689415
First received: September 18, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition
Stroke
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • 24 hour blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  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: NCT01689415

Locations
Denmark
Bispebjerg Hospital, Department of neurology
Copenhagen, Region H, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark
Investigators
Principal Investigator: Hanne Christensen, MD,Ph.D,DMSci Bispebjerg Hospital - Department of neurology
  More Information

Publications:

Responsible Party: Hanne Christensen, Associate Research Professor, Consultant neurologist, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01689415     History of Changes
Other Study ID Numbers: H-4-2012-102
Study First Received: September 18, 2012
Last Updated: July 15, 2014
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
Renal nerve denervation

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014