<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/NCT04423627</url>
  </required_header>
  <id_info>
    <org_study_id>202004244</org_study_id>
    <nct_id>NCT04423627</nct_id>
  </id_info>
  <brief_title>Sympathetic Regulation of Large Artery Stiffness in Humans With ISH</brief_title>
  <acronym>SELECT</acronym>
  <official_title>Sympathetic Regulation of Large Artery Stiffness in Humans With Age-Related Isolated Systolic Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stiffening of your blood vessels, particularly the large vessels from your heart (called the&#xD;
      aorta and carotids) you age contributes to the development of cardiovascular disease (CVD)&#xD;
      such as heart attack and stroke. Nerve activity from your brain to your body also increases&#xD;
      with advancing age but it is unknown if this nerve activity contributes directly to the&#xD;
      stiffening on your blood vessels in older adults in addition to high blood pressure.&#xD;
      Therefore, successful completion of the proposed aims will have a significant clinical impact&#xD;
      by identifying if nerve activity from your brain could be a novel target for therapies that&#xD;
      would lower stiffness of the aorta and carotid arteries in older adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>Early Phase 1</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, placebo controlled, parallel design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in carotid-femoral pulse wave velocity</measure>
    <time_frame>Baseline and after 4 weeks</time_frame>
    <description>Aortic stiffness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in carotid distensibility index</measure>
    <time_frame>Baseline and after 4 weeks</time_frame>
    <description>Change in carotid distensibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in carotid flow pulsatility index</measure>
    <time_frame>Baseline and after 4 weeks</time_frame>
    <description>Change in carotid flow pulsatility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in carotid intimal medial thickness (IMT)</measure>
    <time_frame>Baseline and after 4 weeks</time_frame>
    <description>Change in carotid wall thickness</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Hypertension, Systolic</condition>
  <condition>Stiffness, Aortic</condition>
  <arm_group>
    <arm_group_label>Clonidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.2 mg/day oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>37.5 mg/day oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine</intervention_name>
    <description>Clonidine 0.2 mg/day oral tablet</description>
    <arm_group_label>Clonidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <description>Hydrochlorothiazide 37.5 mg/day oral tablet</description>
    <arm_group_label>Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 60-85&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
          -  clinically healthy&#xD;
&#xD;
          -  untreated or treated stage 1 isolated systolic hypertension (ISH) (systolic BP 130-139&#xD;
             mmHg; diastolic BP &lt;90 mmHg) or stage 2 ISH (systolic BP 140-159 mmHg; diastolic BP&#xD;
             &lt;90 mmHg) per 2017 AHA/ACC hypertension guidelines&#xD;
&#xD;
          -  if subject is on antihypertensive medications, they will stop taking medication for a&#xD;
             one-week washout period after Visit 1 before they return for Visit 2. They will come&#xD;
             in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that&#xD;
             systolic BP is &lt;160 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no history of cardiovascular disease (e.g., myocardial infarction, bypass surgery,&#xD;
             angioplasty/stent, heart failure, cardiomyopathy, pacemaker/defibrillator, peripheral&#xD;
             artery disease), pulmonary disease, liver disease, Type I or II diabetes, cancer&#xD;
             (treated by chemotherapy and/or radiation), psychiatric illness, on aspirin or other&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs).&#xD;
&#xD;
          -  aspirin, NSAIDs, vitamins, herbal supplements, omega-3-fatty acids will have to&#xD;
             discontinue for at least 1 week before participation and remain discontinued during&#xD;
             the study.&#xD;
&#xD;
          -  blood thinners, serotonin reuptake inhibitors (SSRIs), or PDE5 inhibitors will also be&#xD;
             excluded.&#xD;
&#xD;
          -  Women must be postmenopausal for at least 6 months (surgical or natural) and not&#xD;
             currently on hormone replacement therapy.&#xD;
&#xD;
          -  Subjects not on antihypertensive will not be eligible if their resting clinic systolic&#xD;
             BP is &lt;130 mmHg or &gt;160 mmHg and diastolic BP &gt;90 mmHg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary Pierce, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Stroud, RN, MSN</last_name>
    <phone>3193849549</phone>
    <email>amy-stroud@uiowa.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gary L Pierce, PhD</last_name>
    <phone>3193359487</phone>
    <email>gary-pierce@uiowa.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amy Stroud</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Stroud, MSN, RN</last_name>
      <phone>319-356-9549</phone>
      <email>amy-stroud@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Gary L Pierce, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Stroud, MSN, RN</last_name>
      <phone>319-384-9549</phone>
      <email>amy-stroud@uiowa.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Gary L. Pierce</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Isolated Systolic Hypertension</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Clonidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04423627
org study id: 202004244
nct id: NCT04423627
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Stiffening of your blood vessels, particularly the large vessels from your heart (called the
      aorta and carotids) you age contributes to the development of cardiovascular disease (CVD)
      such as heart attack and stroke. Nerve activity from your brain to your body also increases
      with advancing age but it is unknown if this nerve activity contributes directly to the
      stiffening on your blood vessels in older adults in addition to high blood pressure.
      Therefore, successful completion of the proposed aims will have a significant clinical impact
      by identifying if nerve activity from your brain could be a novel target for therapies that
      would lower stiffness of the aorta and carotid arteries in older adults.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, placebo controlled, parallel design
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in carotid-femoral pulse wave velocity
time frame: Baseline and after 4 weeks
description: Aortic stiffness
measure: Change in carotid distensibility index
time frame: Baseline and after 4 weeks
description: Change in carotid distensibility
measure: Change in carotid flow pulsatility index
time frame: Baseline and after 4 weeks
description: Change in carotid flow pulsatility
measure: Change in carotid intimal medial thickness (IMT)
time frame: Baseline and after 4 weeks
description: Change in carotid wall thickness
arm group label: Clonidine
arm group type: Experimental
description: 0.2 mg/day oral
arm group label: Hydrochlorothiazide
arm group type: Active Comparator
description: 37.5 mg/day oral
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Clonidine
description: Clonidine 0.2 mg/day oral tablet
arm group label: Clonidine
intervention type: Drug
intervention name: Hydrochlorothiazide
description: Hydrochlorothiazide 37.5 mg/day oral tablet
arm group label: Hydrochlorothiazide
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary Pierce, PhD
role: Principal Investigator
affiliation: University of Iowa
last name: Amy Stroud, RN, MSN
phone: 3193849549
email: amy-stroud@uiowa.edu
last name: Gary L Pierce, PhD
phone: 3193359487
email: gary-pierce@uiowa.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Gary L. Pierce
investigator title: Associate Professor
mesh term: Hypertension
mesh term: Isolated Systolic Hypertension
mesh term: Systolic Murmurs
mesh term: Hydrochlorothiazide
mesh term: Clonidine
sharing ipd: No