<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/NCT03243045</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE-51310815.0.0000.5272</org_study_id>
    <nct_id>NCT03243045</nct_id>
  </id_info>
  <brief_title>Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation</brief_title>
  <official_title>Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cardiology, Laranjeiras, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Cardiology, Laranjeiras, Brazil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been proposed that the modulation of the activity of the sympathetic nervous system,&#xD;
      through renal sympathetic denervation, besides reducing blood pressure, would promote an&#xD;
      improvement in vascular reactivity and consequent improvement of macro and microcirculation.&#xD;
&#xD;
      The present study aimed to investigate the influence of the renal sympathetic denervation on&#xD;
      the skin microvascular function of patients presenting with resistant arterial hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arterial hypertension is still a serious public health problem with considerable social and&#xD;
      economic impact. Arterial hypertension is the result from a complex interaction between&#xD;
      environmental and genetic factors that initiate and perpetuate elevated blood pressure.&#xD;
      Studies show that about 10% of patients undergoing treatment have resistant hypertension,&#xD;
      defined as high blood pressure refractory to at least three antihypertensive drugs. It is&#xD;
      known that the sympathetic nervous system plays a fundamental role in the pathophysiology of&#xD;
      hypertension, contributing to metabolic and vascular changes. The sympathetic nervous system&#xD;
      has also a major role in the pathophysiology of arterial hypertension. Arterial hypertension&#xD;
      has also been associated with functional microcirculatory alterations as well as systemic&#xD;
      microvascular endothelial dysfunction in hypertensive patients, confirmed by different&#xD;
      microcirculatory flowmetry techniques. In this context, it has been proposed that the&#xD;
      modulation of the sympathetic nervous system through renal sympathetic denervation, besides&#xD;
      reducing blood pressure, would promote an improvement in vascular reactivity and consequent&#xD;
      improvement of macro and microcirculation.&#xD;
&#xD;
      The present study aimed to investigate the influence of the renal sympathetic denervation on&#xD;
      the skin microvascular function of patients with resistant hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Cutaneous microvascular reactivity</measure>
    <time_frame>Before and one, three, six and twelve months after intervention</time_frame>
    <description>Evaluation of microvascular reactivity using laser speckle contrast imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cutaneous microvascular flow</measure>
    <time_frame>Before and one, three, six and twelve months after intervention</time_frame>
    <description>Evaluation of the microvascular flow using laser speckle contrast imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cutaneous capillary density</measure>
    <time_frame>Before and one, three, six and twelve months after intervention</time_frame>
    <description>Evaluation of cutaneous capillary density and reactivity using video-capillaroscopy</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Arterial Hypertension</condition>
  <condition>Resistant Arterial Hypertension</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal sympathetic denervation</intervention_name>
    <description>Transcutaneous renal sympathetic denervation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with a confirmed diagnosis of resistant arterial hypertension who were admitted to&#xD;
        the National Institute of Cardiology (NIC) at the Ministry of Health in Rio de Janeiro,&#xD;
        Brazil. The NIC is a national reference center for the treatment and research of&#xD;
        cardiovascular diseases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resistant arterial hypertension under pharmacological treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary arterial hypertension&#xD;
&#xD;
          -  renal dysfunction&#xD;
&#xD;
          -  severe kidney disease&#xD;
&#xD;
          -  congestive heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>EDUARDO V TIBIRICA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Innstitute of Cardiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Cardiology</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21040-360</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Cardiology, Laranjeiras, Brazil</investigator_affiliation>
    <investigator_full_name>Eduardo Tibirica, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Arterial hypertension</keyword>
  <keyword>Microcirculation</keyword>
  <keyword>Sympathetic nervous system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03243045
org study id: CAAE-51310815.0.0000.5272
nct id: NCT03243045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been proposed that the modulation of the activity of the sympathetic nervous system,
      through renal sympathetic denervation, besides reducing blood pressure, would promote an
      improvement in vascular reactivity and consequent improvement of macro and microcirculation.

      The present study aimed to investigate the influence of the renal sympathetic denervation on
      the skin microvascular function of patients presenting with resistant arterial hypertension.
Arterial hypertension is still a serious public health problem with considerable social and
      economic impact. Arterial hypertension is the result from a complex interaction between
      environmental and genetic factors that initiate and perpetuate elevated blood pressure.
      Studies show that about 10% of patients undergoing treatment have resistant hypertension,
      defined as high blood pressure refractory to at least three antihypertensive drugs. It is
      known that the sympathetic nervous system plays a fundamental role in the pathophysiology of
      hypertension, contributing to metabolic and vascular changes. The sympathetic nervous system
      has also a major role in the pathophysiology of arterial hypertension. Arterial hypertension
      has also been associated with functional microcirculatory alterations as well as systemic
      microvascular endothelial dysfunction in hypertensive patients, confirmed by different
      microcirculatory flowmetry techniques. In this context, it has been proposed that the
      modulation of the sympathetic nervous system through renal sympathetic denervation, besides
      reducing blood pressure, would promote an improvement in vascular reactivity and consequent
      improvement of macro and microcirculation.

      The present study aimed to investigate the influence of the renal sympathetic denervation on
      the skin microvascular function of patients with resistant hypertension.
observational model: Case-Only
time perspective: Prospective
measure: Cutaneous microvascular reactivity
time frame: Before and one, three, six and twelve months after intervention
description: Evaluation of microvascular reactivity using laser speckle contrast imaging
measure: Cutaneous microvascular flow
time frame: Before and one, three, six and twelve months after intervention
description: Evaluation of the microvascular flow using laser speckle contrast imaging
measure: Cutaneous capillary density
time frame: Before and one, three, six and twelve months after intervention
description: Evaluation of cutaneous capillary density and reactivity using video-capillaroscopy
intervention type: Procedure
intervention name: Renal sympathetic denervation
description: Transcutaneous renal sympathetic denervation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: EDUARDO V TIBIRICA, MD, PhD
role: Principal Investigator
affiliation: National Innstitute of Cardiology
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: National Institute of Cardiology, Laranjeiras, Brazil
investigator full name: Eduardo Tibirica, MD, PhD
investigator title: MD, PhD
mesh term: Hypertension