<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/NCT02222077</url>
  </required_header>
  <id_info>
    <org_study_id>Central BP-TOD</org_study_id>
    <nct_id>NCT02222077</nct_id>
  </id_info>
  <brief_title>Central Blood Pressure in Adolescents and Young Adults</brief_title>
  <official_title>Diurnal Variation of Central Blood Pressure in Adolescents and Young Adults and Association With Indices of Asymptomatic Target-organ Damage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate in adolescents and young adults:&#xD;
&#xD;
        -  the 24h diurnal variation of ambulatory central blood pressure&#xD;
&#xD;
        -  the association of central compared to peripheral blood pressure with indices of&#xD;
           asymptomatic target-organ damage&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage</measure>
    <time_frame>Assessment of each individual will require up to 3 days</time_frame>
    <description>Correlation coefficients (r) will be determined for the relationship between central blood pressure and indices of target-organ damage (left ventricular mass index, carotid intima-media thickness, pulse wave velocity). Also, these coefficients will be compared with z-statistic with the respective ones for the peripheral blood pressure.</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Healthy</condition>
  <condition>Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers and subjects referred to the Hypertension Clinic for the assessment of&#xD;
        elevated blood pressure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents and young adults (age range 12-25 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any acute or significant chronic disease, with evidence of secondary&#xD;
             hypertension, or on regular drug treatment will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>George S Stergiou, Professor of Medicine</last_name>
    <phone>+302107763117</phone>
    <email>gstergi@med.uoa.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hypertension Center, 3rd University Department of Medicine, Sotiria Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George S Stergiou, Professor of Medicine</last_name>
      <phone>+302107763117</phone>
      <email>gstergi@med.uoa.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>George S. Stergiou</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Central blood pressure</keyword>
  <keyword>Ambulatory blood pressure monitoring</keyword>
  <keyword>Target-organ damage</keyword>
  <keyword>Adolescents and young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT02222077
org study id: Central BP-TOD
nct id: NCT02222077
lead sponsor: 
has dmc: No
This study aims to investigate in adolescents and young adults:

        -  the 24h diurnal variation of ambulatory central blood pressure

        -  the association of central compared to peripheral blood pressure with indices of
           asymptomatic target-organ damage
observational model: Cohort
time perspective: Cross-Sectional
measure: Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage
time frame: Assessment of each individual will require up to 3 days
description: Correlation coefficients (r) will be determined for the relationship between central blood pressure and indices of target-organ damage (left ventricular mass index, carotid intima-media thickness, pulse wave velocity). Also, these coefficients will be compared with z-statistic with the respective ones for the peripheral blood pressure.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: George S Stergiou, Professor of Medicine
phone: +302107763117
email: gstergi@med.uoa.gr
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: George S. Stergiou
investigator title: Professor of Medicine
mesh term: Hypertension