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

September 18, 2012
July 15, 2014
September 2012
January 2014   (final data collection date for primary outcome measure)
24 hour blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01689415 on ClinicalTrials.gov Archive Site
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Renal Denervation Hypertension After Stroke
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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Stroke
  • Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
November 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01689415
H-4-2012-102
No
Hanne Christensen, Bispebjerg Hospital
Bispebjerg Hospital
Rigshospitalet, Denmark
Principal Investigator: Hanne Christensen, MD,Ph.D,DMSci Bispebjerg Hospital - Department of neurology
Bispebjerg Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP