<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689415</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2012-102</org_study_id>
    <nct_id>NCT01689415</nct_id>
  </id_info>
  <brief_title>Renal Denervation Hypertension After Stroke</brief_title>
  <acronym>REHEARSE</acronym>
  <official_title>Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood&#xD;
      pressure reduction - together with antithrombotics - remain crucial in stroke prevention.&#xD;
&#xD;
      This pilot study will examine the effect of renal nerve denervation in patients with&#xD;
      treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24&#xD;
      hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6&#xD;
      and 12 months after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method&#xD;
      used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys&#xD;
      ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in&#xD;
      patients with treatment resistant hypertension.&#xD;
&#xD;
      The hypothesis is that RDN is able to reduce the blood pressure in patients with previous&#xD;
      stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke.&#xD;
&#xD;
      Aim of study:&#xD;
&#xD;
        1. To validate the reduction in blood pressure after RND in patients with stroke and&#xD;
           treatment resistant hypertension compared to the results achieved in patients only with&#xD;
           essential hypertension&#xD;
&#xD;
        2. To examine if this treatment is possible on patients after stroke (procedure related&#xD;
           limitations and security of the patient)&#xD;
&#xD;
        3. To describe the effect of RND in the development of changes in the white matter over&#xD;
           time&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on results from SYMPLICITY HTN-3&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour blood pressure</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Stroke</condition>
  <condition>Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the study population must be 18+ years old and have a clinical verified stroke&#xD;
        within the last year and treatment resistant hypertension at 150 mm Hg or higher systolic&#xD;
        at consultation. The patients Modified Ranking Scale must be between 0-2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years old&#xD;
&#xD;
          -  Clinical verified stroke within the last year&#xD;
&#xD;
          -  Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation&#xD;
&#xD;
          -  Modified Ranking between 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Renal artery anatomy, which prevents the procedure&#xD;
&#xD;
          -  Reno vascular disease&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Haemodynamic vascular occlusion or valve disease&#xD;
&#xD;
          -  Pregnancy or women in the childbearing age&#xD;
&#xD;
          -  Secondary hypertension&#xD;
&#xD;
          -  Mean systolic blood pressure over 180 mm Hg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanne Christensen, MD,Ph.D,DMSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bispebjerg Hospital - Department of neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg Hospital, Department of neurology</name>
      <address>
        <city>Copenhagen</city>
        <state>Region H</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Friday G, Alter M, Lai SM. Control of hypertension and risk of stroke recurrence. Stroke. 2002 Nov;33(11):2652-7. doi: 10.1161/01.str.0000033929.62136.6f.</citation>
    <PMID>12411656</PMID>
  </reference>
  <reference>
    <citation>van Gijn J. The PROGRESS Trial: preventing strokes by lowering blood pressure in patients with cerebral ischemia. Emerging therapies: critique of an important advance. Stroke. 2002 Jan;33(1):319-20. No abstract available.</citation>
    <PMID>11779934</PMID>
  </reference>
  <reference>
    <citation>Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. doi: 10.1097/01.hjh.0000174968.72212.ac.</citation>
    <PMID>16003165</PMID>
  </reference>
  <reference>
    <citation>Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, O'Connor PJ, Selby JV, Ho PM. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012 Apr 3;125(13):1635-42. doi: 10.1161/CIRCULATIONAHA.111.068064. Epub 2012 Feb 29.</citation>
    <PMID>22379110</PMID>
  </reference>
  <reference>
    <citation>Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis. 2011 Jan-Feb;20(1):16-23. doi: 10.1016/j.jstrokecerebrovasdis.2009.10.002. Epub 2010 Jun 17.</citation>
    <PMID>21187254</PMID>
  </reference>
  <reference>
    <citation>Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.</citation>
    <PMID>19332353</PMID>
  </reference>
  <reference>
    <citation>Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.</citation>
    <PMID>21093036</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Hanne Christensen</investigator_full_name>
    <investigator_title>Associate Research Professor, Consultant neurologist</investigator_title>
  </responsible_party>
  <keyword>Renal nerve denervation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689415
org study id: H-4-2012-102
nct id: NCT01689415
lead sponsor: 
collaborator: 
has dmc: No
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 model: Case-Only
time perspective: Prospective
measure: 24 hour blood pressure
time frame: 3 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanne Christensen, MD,Ph.D,DMSci
role: Principal Investigator
affiliation: Bispebjerg Hospital - Department of neurology
facility: 
country: Denmark
citation: Friday G, Alter M, Lai SM. Control of hypertension and risk of stroke recurrence. Stroke. 2002 Nov;33(11):2652-7. doi: 10.1161/01.str.0000033929.62136.6f.
PMID: 12411656
citation: van Gijn J. The PROGRESS Trial: preventing strokes by lowering blood pressure in patients with cerebral ischemia. Emerging therapies: critique of an important advance. Stroke. 2002 Jan;33(1):319-20. No abstract available.
PMID: 11779934
citation: Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. doi: 10.1097/01.hjh.0000174968.72212.ac.
PMID: 16003165
citation: Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, O'Connor PJ, Selby JV, Ho PM. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012 Apr 3;125(13):1635-42. doi: 10.1161/CIRCULATIONAHA.111.068064. Epub 2012 Feb 29.
PMID: 22379110
citation: Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis. 2011 Jan-Feb;20(1):16-23. doi: 10.1016/j.jstrokecerebrovasdis.2009.10.002. Epub 2010 Jun 17.
PMID: 21187254
citation: Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
PMID: 19332353
citation: Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
PMID: 21093036
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Hanne Christensen
investigator title: Associate Research Professor, Consultant neurologist
mesh term: Stroke
mesh term: Hypertension