<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/NCT02213575</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201500594 -N</org_study_id>
    <secondary_id>RO1HL3361028</secondary_id>
    <secondary_id>2013-00102 Study 3</secondary_id>
    <secondary_id>R01HL132448</secondary_id>
    <nct_id>NCT02213575</nct_id>
  </id_info>
  <brief_title>Study 3: Minocycline Decreases Microglia Activation</brief_title>
  <official_title>Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a mechanistic study that will enroll 9 subjects who are participating in&#xD;
      NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that&#xD;
      minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic&#xD;
      hypertensive individuals) to test whether the antihypertensive effect of minocycline is&#xD;
      associated with a decrease in activated microglia in central nervous system autonomic regions&#xD;
      as evidenced by changes in PET and MRI imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will recruit 9 subjects from NCT02133885 who will agree to undergo additional&#xD;
      autonomic testing and imaging studies at baseline and after 3-6 months of study treatment.&#xD;
      Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission&#xD;
      tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in&#xD;
      Montreal Canada.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 15, 2024</start_date>
  <completion_date type="Anticipated">October 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRI changes in the paraventricular nucleus</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>MRI changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI changes in the paraventricular nucleus</measure>
    <time_frame>Change in Baseline to 24 weeks</time_frame>
    <description>MRI changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PET changes in the paraventricular nucleus</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>PET changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PET changes in the paraventricular nucleus</measure>
    <time_frame>Change in Baseline to 24 weeks</time_frame>
    <description>PET changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">9</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Minocycline</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <description>Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.</description>
    <arm_group_label>Minocycline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects participating in IRB approved protocol #102-2013 will be eligible to&#xD;
             participate.&#xD;
&#xD;
          -  (For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized&#xD;
             imaging of the participant's brain using magnetic resonance imaging (MRI), positron&#xD;
             emission tomography (PET) scanning, Autonomic Nervous System Testing and blood&#xD;
             drawing- if participant qualifies&#xD;
&#xD;
        Exclusion criteria for control and resistant hypertensive subjects include:&#xD;
&#xD;
          -  currently pregnant or have been pregnant in the last 6 months;&#xD;
&#xD;
          -  antibiotic treatment within 2 months of study enrollment;&#xD;
&#xD;
          -  currently taking a medication (e.g., antibiotic, anti-inflammatory agents,&#xD;
             glucocorticoids or other immune modulating medications);&#xD;
&#xD;
          -  unwilling to discontinue vitamin or supplements, including probiotics, potentially&#xD;
             affecting gut microbiota (vitamins/supplements and medications that possibly affect&#xD;
             the gut microbiota should be discontinued for at least 2wks prior to stool&#xD;
             collection);&#xD;
&#xD;
          -  history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose&#xD;
             intolerance, chronic pancreatitis or other malabsorption disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl Pepine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dana Leach, DNP</last_name>
    <phone>352-273-8933</phone>
    <email>leachdd@medicine.ufl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Long, RN</last_name>
    <phone>352-273-8933</phone>
    <email>sarah.long@medicine.ufl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UF Health Cardiovascular Clinic</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Resistent Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</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/NCT02213575
org study id: IRB201500594 -N
secondary id: RO1HL3361028
secondary id: 2013-00102 Study 3
secondary id: R01HL132448
nct id: NCT02213575
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is a mechanistic study that will enroll 9 subjects who are participating in
      NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that
      minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic
      hypertensive individuals) to test whether the antihypertensive effect of minocycline is
      associated with a decrease in activated microglia in central nervous system autonomic regions
      as evidenced by changes in PET and MRI imaging.
This study will recruit 9 subjects from NCT02133885 who will agree to undergo additional
      autonomic testing and imaging studies at baseline and after 3-6 months of study treatment.
      Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission
      tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in
      Montreal Canada.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MRI changes in the paraventricular nucleus
time frame: Change from baseline to 12 weeks
description: MRI changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
measure: MRI changes in the paraventricular nucleus
time frame: Change in Baseline to 24 weeks
description: MRI changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
measure: PET changes in the paraventricular nucleus
time frame: Change from baseline to 12 weeks
description: PET changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
measure: PET changes in the paraventricular nucleus
time frame: Change in Baseline to 24 weeks
description: PET changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
arm group label: Minocycline
arm group type: Other
description: Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.
intervention type: Drug
intervention name: Minocycline
description: Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.
arm group label: Minocycline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Carl Pepine, MD
role: Principal Investigator
affiliation: University of Florida
last name: Dana Leach, DNP
phone: 352-273-8933
email: leachdd@medicine.ufl.edu
last name: Sarah Long, RN
phone: 352-273-8933
email: sarah.long@medicine.ufl.edu
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Minocycline