<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/NCT03816462</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00056175</org_study_id>
    <nct_id>NCT03816462</nct_id>
  </id_info>
  <brief_title>ReNEW Clinic Cohort Study</brief_title>
  <acronym>ReNEW</acronym>
  <official_title>Reversing the Negative Cardiovascular Effects of Weight (ReNEW) Clinic Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</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 is an ongoing, prospective cohort study of children and young adults who are evaluated&#xD;
      in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins&#xD;
      University.&#xD;
&#xD;
      Demographic and clinical data of patients who agree to participate are obtained via chart&#xD;
      review and entered into a longitudinal clinic registry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">September 2030</completion_date>
  <primary_completion_date type="Anticipated">September 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demographic and clinical data obtained via chart review</measure>
    <time_frame>20 years</time_frame>
    <description>This is a clinic based registry of cardiovascular disease risk data from participants to be collected over time.</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hypertension</condition>
  <condition>Prehypertension</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Left Ventricular Hypertrophy</condition>
  <condition>Elevated Blood Pressure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children between birth and 22 years of age with overweight or obesity referred for&#xD;
        evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Children and young adults with overweight or obesity referred for evaluation of&#xD;
             elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are wards of the state or who are non-English speaking without an&#xD;
             in-person interpreter accompanying them to the clinic visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tammy M Brady</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tammy M Brady, M.D., PhD</last_name>
    <phone>410.955.2467</phone>
    <email>tbrady8@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tammy Brady, M.D., PhD</last_name>
      <phone>410-955-2467</phone>
      <email>tbrady8@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Thomas Dell</last_name>
      <email>tdell1@jhmi.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypertrophy, Left Ventricular</mesh_term>
    <mesh_term>Prehypertension</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hypertrophy</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/NCT03816462
org study id: IRB00056175
nct id: NCT03816462
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an ongoing, prospective cohort study of children and young adults who are evaluated
      in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins
      University.

      Demographic and clinical data of patients who agree to participate are obtained via chart
      review and entered into a longitudinal clinic registry.
observational model: Cohort
time perspective: Prospective
measure: Demographic and clinical data obtained via chart review
time frame: 20 years
description: This is a clinic based registry of cardiovascular disease risk data from participants to be collected over time.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 22 Years
healthy volunteers: No
last name: Tammy M Brady
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Tammy M Brady, M.D., PhD
phone: 410.955.2467
email: tbrady8@jhmi.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Hypertrophy, Left Ventricular
mesh term: Prehypertension
mesh term: Overweight
mesh term: Hypertrophy