<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/NCT03778489</url>
  </required_header>
  <id_info>
    <org_study_id>PANX-HYP</org_study_id>
    <nct_id>NCT03778489</nct_id>
  </id_info>
  <brief_title>Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension</brief_title>
  <acronym>IMPROVEH</acronym>
  <official_title>Impact of Aerobic Exercise Training on Sympathetically Mediated Vasoconstriction and Vascular Function in Individuals With Essential Hypertension (IMPROVEH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Council for Independent Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sympathetic nervous activity plays an important role in the development of hypertension and&#xD;
      studies have shown that the pannexin-1 channel is involved in the signalling of the&#xD;
      sympathetic activity to the vascular bed. The main project aim is to investigate the effects&#xD;
      of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on&#xD;
      vascular function in individuals with essential hypertension. A secondary aim is to assess&#xD;
      the role of essential hypertension and physical activity on vascular endothelial function,&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized double blinded case-control interventional study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Changes in systolic and diastolic blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pannexin channel function assessed in vivo</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pannexin channel distribution in skeletal muscle tissue</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Pannexin channel distribution is assessed immunohistochemically in muscle samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathetic activity</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Direct measurement of Muscle Sympathetic Nervous Activity via microneurography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitochondrial function in endothelial cells</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive oxygen species formation in in endothelial cells</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rheology</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet reactivity</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Platelet reactivity is assessed by multiplate aggregometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Direct Measurement of oxygen uptake during a graded test on cycle ergometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Measured by Dual energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial cell characterization</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Assessment of protein and mRNA-levels of proteins of relevance for endothelial function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal muscle characterization</measure>
    <time_frame>Before and after 8 weeks of training</time_frame>
    <description>Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypertension,Essential</condition>
  <arm_group>
    <arm_group_label>Hypertensive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men and women in age-group 35-65 years Resting blood pressure of &gt;140/90 mmHg non or only anti-hypertensive medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men and women in age-group 35-65 years Resting blood pressure of &lt;140/90 mmHg no medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Hypertensive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary men and women age 35 - 65 years&#xD;
&#xD;
          -  Resting blood pressure &gt;140/90 mmHg or Resting blood pressure &lt;140/90 mmHg&#xD;
&#xD;
          -  Essential hypertension&#xD;
&#xD;
          -  Non or exclusively antihypertensive medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertensive condition other than essential hypertension&#xD;
&#xD;
          -  Other chronical diseases&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Excess alcohol intake or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Ylva Hellsten</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pannexin-1 channel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Currently awaiting instructions on this issue from the department</ipd_description>
  </patient_data>
  <!-- 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/NCT03778489
org study id: PANX-HYP
nct id: NCT03778489
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Sympathetic nervous activity plays an important role in the development of hypertension and
      studies have shown that the pannexin-1 channel is involved in the signalling of the
      sympathetic activity to the vascular bed. The main project aim is to investigate the effects
      of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on
      vascular function in individuals with essential hypertension. A secondary aim is to assess
      the role of essential hypertension and physical activity on vascular endothelial function,
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized double blinded case-control interventional study
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Blood pressure
time frame: Before and after 8 weeks of training
description: Changes in systolic and diastolic blood pressure
measure: Pannexin channel function assessed in vivo
time frame: Before and after 8 weeks of training
description: Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition
measure: Pannexin channel distribution in skeletal muscle tissue
time frame: Before and after 8 weeks of training
description: Pannexin channel distribution is assessed immunohistochemically in muscle samples
measure: Sympathetic activity
time frame: Before and after 8 weeks of training
description: Direct measurement of Muscle Sympathetic Nervous Activity via microneurography
measure: Vascular function
time frame: Before and after 8 weeks of training
description: Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances
measure: Mitochondrial function in endothelial cells
time frame: Before and after 8 weeks of training
description: Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry
measure: Reactive oxygen species formation in in endothelial cells
time frame: Before and after 8 weeks of training
description: Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry
measure: Rheology
time frame: Before and after 8 weeks of training
description: Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.
measure: Platelet reactivity
time frame: Before and after 8 weeks of training
description: Platelet reactivity is assessed by multiplate aggregometry
measure: Maximal oxygen uptake
time frame: Before and after 8 weeks of training
description: Direct Measurement of oxygen uptake during a graded test on cycle ergometer
measure: Body Composition
time frame: Before and after 8 weeks of training
description: Measured by Dual energy x-ray absorptiometry
measure: Endothelial cell characterization
time frame: Before and after 8 weeks of training
description: Assessment of protein and mRNA-levels of proteins of relevance for endothelial function
measure: Skeletal muscle characterization
time frame: Before and after 8 weeks of training
description: Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function
arm group label: Hypertensive
arm group type: Experimental
description: Men and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication
arm group label: Control
arm group type: Active Comparator
description: Men and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication
intervention type: Other
intervention name: Training
description: 10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
arm group label: Control
arm group label: Hypertensive
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Ylva Hellsten
investigator title: Professor
mesh term: Hypertension
mesh term: Essential Hypertension
sharing ipd: Undecided
ipd description: Currently awaiting instructions on this issue from the department