<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/NCT03762499</url>
  </required_header>
  <id_info>
    <org_study_id>247606</org_study_id>
    <nct_id>NCT03762499</nct_id>
  </id_info>
  <brief_title>Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.</brief_title>
  <acronym>HyperEcho</acronym>
  <official_title>Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</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>
      HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline&#xD;
      transthoracic echocardiography along with routine data collected in the hypertension clinic&#xD;
      can guide clinicians to better manage, and improve risk stratification for cardiovascular&#xD;
      disease in young adults with hypertension. Participants are characterised as young adult&#xD;
      patients aged between 18 to 40 years old and referred to the hypertension clinic to manage&#xD;
      their blood pressure. The study visit will be carried out during the planned routine visit of&#xD;
      the participants to the hypertension clinics of NHS trusts within England. Routine data will&#xD;
      be collected by the assigned nurse for the hypertension clinic as part of the clinical&#xD;
      service, and research participation will not affect the clinical progress of the participant.&#xD;
      The additional research component to the clinic will be asking the participants for their&#xD;
      consent to undergo a research echocardiography scan if it has not been a part of their&#xD;
      clinical assessment. Participants will also be asked to consent to the use of their data that&#xD;
      has been collected in the hypertension clinic, such as; referral letters, medical history,&#xD;
      24-hour blood pressure monitoring report, ECG, blood samples, body fat composition, and&#xD;
      dietary questionnaire. In addition to this, participants will be asked to consent to further&#xD;
      review of their data and medical notes during their follow up visits (up to 10 years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline&#xD;
      transthoracic echocardiography along with routine data collected in the hypertension clinic&#xD;
      can guide clinicians to better manage, and improve risk stratification for cardiovascular&#xD;
      disease in young adults with hypertension. Participants are characterised as hypertensive&#xD;
      patients aged between 18 to 40 years old and referred to the hypertension clinic to manage&#xD;
      their blood pressure. A patient and public involvement exercise has been performed to ensure&#xD;
      this study design would appeal to patients attending the hypertension clinic, and to&#xD;
      investigate the preferred method of contact.&#xD;
&#xD;
      The study visit will be carried out during the planned routine visit of the participants to&#xD;
      the hypertension clinics of NHS trusts within England. Routine data will be collected by the&#xD;
      assigned nurse for the hypertension clinic as part of the clinical service, and research&#xD;
      participation will not affect the clinical progress of the participant. The additional&#xD;
      research component to the clinic will be asking the participants for their consent to undergo&#xD;
      a research echocardiography scan if it has not been a part of their clinical assessment.&#xD;
      Participants will also be asked to consent to the use of their data that has been collected&#xD;
      in the hypertension clinic, such as; referral letters, medical history, 24-hour blood&#xD;
      pressure monitoring report, ECG, blood samples, body fat composition, and dietary&#xD;
      questionnaire. In addition to this, participants will be asked to consent to further review&#xD;
      of their data and medical notes during their follow up visits (up to 10 years).&#xD;
&#xD;
      Previous young adult patients who visited the Hypertension clinics in the last 10 years will&#xD;
      be also recruited. This cohort will be asked to consent to allow the research team to collect&#xD;
      and use their clinical data as well as follow up their medical notes. They will not actively&#xD;
      participate in the study as they will not require visiting the hypertension clinic or&#xD;
      undergoing an echocardiography scan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">October 2, 2028</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of patient clusters based on echocardiographic and clinical findings</measure>
    <time_frame>Obtained at the first clinical visit</time_frame>
    <description>Number of hypertension patient clusters based on echocardiographic and clinical findings</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Prospective participants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>250 participants will be recruited prospectively during the hypertension clinic, where a full set of data will be collected from each participant as part of their standard hypertension clinical service. An additional echocardiography scan will be performed for this cohort by the study team, if the scan has not been performed as a part of the clinical care service</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retrospective participants</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography scan</intervention_name>
    <description>Non-invasive ultrasound imaging of the heart.</description>
    <arm_group_label>Prospective participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 - 40 years (at the time of their appointment at the&#xD;
             hypertension clinic).&#xD;
&#xD;
          -  Referred for a Hypertension Clinic in England.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to give valid consent for participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maryam Alsharqi</last_name>
    <phone>+44(0)1865 572832</phone>
    <email>maryam.alsharqi@cardiov.ox.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cardiovascular Clinical Research Facility</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maryam Alsharqi</last_name>
      <phone>+44(0)1865 572832</phone>
      <email>maryam.alsharqi@cardiov.ox.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Young adults</keyword>
  <keyword>Echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03762499
org study id: 247606
nct id: NCT03762499
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline
      transthoracic echocardiography along with routine data collected in the hypertension clinic
      can guide clinicians to better manage, and improve risk stratification for cardiovascular
      disease in young adults with hypertension. Participants are characterised as young adult
      patients aged between 18 to 40 years old and referred to the hypertension clinic to manage
      their blood pressure. The study visit will be carried out during the planned routine visit of
      the participants to the hypertension clinics of NHS trusts within England. Routine data will
      be collected by the assigned nurse for the hypertension clinic as part of the clinical
      service, and research participation will not affect the clinical progress of the participant.
      The additional research component to the clinic will be asking the participants for their
      consent to undergo a research echocardiography scan if it has not been a part of their
      clinical assessment. Participants will also be asked to consent to the use of their data that
      has been collected in the hypertension clinic, such as; referral letters, medical history,
      24-hour blood pressure monitoring report, ECG, blood samples, body fat composition, and
      dietary questionnaire. In addition to this, participants will be asked to consent to further
      review of their data and medical notes during their follow up visits (up to 10 years).
HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline
      transthoracic echocardiography along with routine data collected in the hypertension clinic
      can guide clinicians to better manage, and improve risk stratification for cardiovascular
      disease in young adults with hypertension. Participants are characterised as hypertensive
      patients aged between 18 to 40 years old and referred to the hypertension clinic to manage
      their blood pressure. A patient and public involvement exercise has been performed to ensure
      this study design would appeal to patients attending the hypertension clinic, and to
      investigate the preferred method of contact.

      The study visit will be carried out during the planned routine visit of the participants to
      the hypertension clinics of NHS trusts within England. Routine data will be collected by the
      assigned nurse for the hypertension clinic as part of the clinical service, and research
      participation will not affect the clinical progress of the participant. The additional
      research component to the clinic will be asking the participants for their consent to undergo
      a research echocardiography scan if it has not been a part of their clinical assessment.
      Participants will also be asked to consent to the use of their data that has been collected
      in the hypertension clinic, such as; referral letters, medical history, 24-hour blood
      pressure monitoring report, ECG, blood samples, body fat composition, and dietary
      questionnaire. In addition to this, participants will be asked to consent to further review
      of their data and medical notes during their follow up visits (up to 10 years).

      Previous young adult patients who visited the Hypertension clinics in the last 10 years will
      be also recruited. This cohort will be asked to consent to allow the research team to collect
      and use their clinical data as well as follow up their medical notes. They will not actively
      participate in the study as they will not require visiting the hypertension clinic or
      undergoing an echocardiography scan.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Identification of patient clusters based on echocardiographic and clinical findings
time frame: Obtained at the first clinical visit
description: Number of hypertension patient clusters based on echocardiographic and clinical findings
arm group label: Prospective participants
arm group type: Active Comparator
description: 250 participants will be recruited prospectively during the hypertension clinic, where a full set of data will be collected from each participant as part of their standard hypertension clinical service. An additional echocardiography scan will be performed for this cohort by the study team, if the scan has not been performed as a part of the clinical care service
arm group label: Retrospective participants
arm group type: No Intervention
description: 500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
intervention type: Diagnostic Test
intervention name: Echocardiography scan
description: Non-invasive ultrasound imaging of the heart.
arm group label: Prospective participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Maryam Alsharqi
phone: +44(0)1865 572832
email: maryam.alsharqi@cardiov.ox.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes