<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/NCT04479813</url>
  </required_header>
  <id_info>
    <org_study_id>REG 15-021</org_study_id>
    <nct_id>NCT04479813</nct_id>
  </id_info>
  <brief_title>Role of Sympathetic Activation in Ischemia Reperfusion Injury</brief_title>
  <official_title>Role of Sympathetic Activation in Ischemia Reperfusion Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Perth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Perth Hospital</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>
      This study is designed to assess the effect of forearm ischemia-reperfusion injury on&#xD;
      sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a&#xD;
      contributor to the protective effects of remote ischemic preconditioning. In addition it will&#xD;
      assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate&#xD;
      ischemia reperfusion injury induced endothelial dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized single blind study where subjects will be allocated to undergo one of&#xD;
      the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20&#xD;
      minutes prior to the first endothelial function measurement.&#xD;
&#xD;
      This medication acts by reducing the activity of nerves believed to be involved in the&#xD;
      conditioning process. The placebo pill, designed to have no effect, will be used as a&#xD;
      comparison. Comprehensive tests will occur which include Microneurography, Endothelial&#xD;
      function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2015</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in muscle sympathetic nerve activity</measure>
    <time_frame>1 day</time_frame>
    <description>Muscle sympathetic nerve activity assessed by microneurography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelial Function using the EndoPat2000 device</measure>
    <time_frame>2 days</time_frame>
    <description>Endothelial Function testing involves the measurement of pulse amplitude from the tip of each index finger at rest and after a period of occlusion using an arm cuff that is manually inflated to a level above that of the participant's Blood Pressure (BP).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Central Sympathetic Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>No conditioning + placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No conditioning + moxonidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote pre-conditioning + placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote pre-conditioning + moxonidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxonidine 0.2 MG</intervention_name>
    <description>Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.</description>
    <arm_group_label>No conditioning + moxonidine</arm_group_label>
    <arm_group_label>Remote pre-conditioning + moxonidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.</description>
    <arm_group_label>No conditioning + placebo</arm_group_label>
    <arm_group_label>Remote pre-conditioning + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy males, not on any medication, free of any history of metabolic, cardiovascular&#xD;
             or cerebrovascular disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>50 healthy male volunteers (25 aged 18-30 years and 25 aged 60-75 years)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Schlaich, MD,FAHA,FESC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Perth Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dobney Hypertension Centre</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Perth Hospital</investigator_affiliation>
    <investigator_full_name>Dr Markus Schlaich</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ischemia</keyword>
  <keyword>re-perfusion</keyword>
  <keyword>Remote conditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Autonomic Nervous System Diseases</mesh_term>
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxonidine</mesh_term>
  </intervention_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/NCT04479813
org study id: REG 15-021
nct id: NCT04479813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to assess the effect of forearm ischemia-reperfusion injury on
      sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a
      contributor to the protective effects of remote ischemic preconditioning. In addition it will
      assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate
      ischemia reperfusion injury induced endothelial dysfunction.
This is a randomized single blind study where subjects will be allocated to undergo one of
      the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20
      minutes prior to the first endothelial function measurement.

      This medication acts by reducing the activity of nerves believed to be involved in the
      conditioning process. The placebo pill, designed to have no effect, will be used as a
      comparison. Comprehensive tests will occur which include Microneurography, Endothelial
      function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: change in muscle sympathetic nerve activity
time frame: 1 day
description: Muscle sympathetic nerve activity assessed by microneurography
measure: Endothelial Function using the EndoPat2000 device
time frame: 2 days
description: Endothelial Function testing involves the measurement of pulse amplitude from the tip of each index finger at rest and after a period of occlusion using an arm cuff that is manually inflated to a level above that of the participant's Blood Pressure (BP).
arm group label: No conditioning + placebo
arm group type: Experimental
description: Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
arm group label: No conditioning + moxonidine
arm group type: Experimental
description: Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
arm group label: Remote pre-conditioning + placebo
arm group type: Experimental
description: Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
arm group label: Remote pre-conditioning + moxonidine
arm group type: Experimental
description: Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
intervention type: Drug
intervention name: Moxonidine 0.2 MG
description: Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
arm group label: No conditioning + moxonidine
arm group label: Remote pre-conditioning + moxonidine
intervention type: Other
intervention name: placebo
description: Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
arm group label: No conditioning + placebo
arm group label: Remote pre-conditioning + placebo
criteria: 
gender: Male
gender based: Yes
gender description: 50 healthy male volunteers (25 aged 18-30 years and 25 aged 60-75 years)
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markus Schlaich, MD,FAHA,FESC
role: Principal Investigator
affiliation: Royal Perth Hospital
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Royal Perth Hospital
investigator full name: Dr Markus Schlaich
investigator title: Principal Investigator
mesh term: Nervous System Diseases
mesh term: Autonomic Nervous System Diseases
mesh term: Reperfusion Injury
mesh term: Ischemia
mesh term: Moxonidine