<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/NCT03014791</url>
  </required_header>
  <id_info>
    <org_study_id>AWE</org_study_id>
    <nct_id>NCT03014791</nct_id>
  </id_info>
  <brief_title>Influence of Age, Weight and Ethnic Background on Blood Pressure</brief_title>
  <acronym>AWE</acronym>
  <official_title>Influence of Age, Weight and Ethnic Background on Blood Pressure: AWE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension, also known as high blood pressure, is a chronic medical condition, in which the&#xD;
      blood pressure is elevated. This is a common condition, which can lead to severe&#xD;
      complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not&#xD;
      detected and treated early.&#xD;
&#xD;
      Accumulating evidence suggests that the incidence of hypertension varies according to age,&#xD;
      ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological&#xD;
      mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates&#xD;
      of elevated blood pressure across the adult age-span, and determine the extent to which body&#xD;
      size and ethnicity impact on these associations. We also wish to investigate the impact of&#xD;
      hypertension on key target organs (end-organ damage). The primary objective of this study is&#xD;
      to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive&#xD;
      participants across the adult age span, and to assess the influence of body mass index and&#xD;
      ethnic background on these mechanisms. Secondary objectives are to investigate the&#xD;
      association between blood pressure and cardiovascular physiology across the adult age span at&#xD;
      rest and during sub-maximal exercise and to investigate the impact of blood pressure&#xD;
      haemodynamics on key organs including the arteries and heart by assessing end-organ damage&#xD;
      such as endothelial function, arterial structure and left ventricular mass/function.&#xD;
&#xD;
      This study will be a combined case-control and cross-sectional study describing the&#xD;
      procedures and time commitment required to investigate our scientific aims. This is a single&#xD;
      centre study that will be conducted in a secondary care environment. Both male and females&#xD;
      aged 18 and over and that are able provide informed consent will be considered for this&#xD;
      study. People who are pregnant, currently receiving dialysis, illness with a life expectancy&#xD;
      &lt;1 year, current active malignancy and cannot provide informed consent are ineligible for&#xD;
      this study. The study will be open for five years and each patient will complete a maximum of&#xD;
      four visits in a 12 month period. Participants will complete a variety of non-invasive&#xD;
      physiological assessments of their cardiovascular system and lung function. There will be&#xD;
      some minimally invasive procedures completed, including a blood test and assessment of small&#xD;
      artery endothelial function which involves insertion of a small needle under local&#xD;
      anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Output (Measured by the inert gas re-breathing technique L/Min)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Vascular Diseases</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>No IMP to be administered, only challenge agents as part of the physiological assessments.&#xD;
Large artery endothelial function:&#xD;
Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)&#xD;
Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)&#xD;
Forearm blood flow&#xD;
Acetylcholine: 7.5μg/min, 15μg/min and 30μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)&#xD;
Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)&#xD;
LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <description>No IMP to be administered, only challenge agents as part of the physiological assessments.&#xD;
Large artery endothelial function:&#xD;
Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)&#xD;
Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)&#xD;
Forearm blood flow&#xD;
Acetylcholine: 7.5μg/min, 15μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)&#xD;
Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)&#xD;
LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
    <description>No IMP to be administered, only challenge agents as part of the physiological assessments.&#xD;
Large artery endothelial function:&#xD;
Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms&#xD;
Forearm blood flow Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms&#xD;
Recruited from community-based cohort studies - CLEAREST and ACCT&#xD;
Equal recruitment across the following parameters:&#xD;
Age: 3 groups &lt;30, 30-60, &gt;60 years&#xD;
Gender&#xD;
BMI: 3 groups &lt;25, 25-30, &gt;30 Kg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief lifestyle/medical history questionnaire</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anthropometric measures</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood pressure and arterial stiffness</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac output and lung function</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Heart rate variability</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample &amp; spot urine sample</intervention_name>
    <description>Core Measurement</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>24 hour ambulatory blood pressure monitor</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>24 hour urine collection</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echocardiograph: Left ventricular mass</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Large artery structure: Carotid intima-media thickness</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Small artery structure: Minimum forearm vascular resistance</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Large artery endothelial function</intervention_name>
    <description>Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Small artery endothelial function: Forearm blood flow</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dundee step test</intervention_name>
    <description>Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Detailed haemodynamic response to submaximal exercise</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiopulmonary fitness: Maximum oxygen consumption</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Haemodynamic response to mental stress</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Small artery dilatory function: Forearm blood flow</intervention_name>
    <description>Detailed Measurement (Optional for participants).</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Hypertensive Patients (Case-control)</arm_group_label>
    <arm_group_label>Hypertensive Patients (Cross-sectional)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During the study, the blood and urine samples will be stored by the research team at the&#xD;
      department of Experimental Medicine and Immunotherapeutics, Division of Cardiovascular&#xD;
      Medicine under the responsibility of the CI who will ensure the security and confidentiality&#xD;
      of the stored material. These samples will not be accessible to any investigator outside the&#xD;
      research team. A small aliquot of the participant's blood and urine sample will be stored at&#xD;
      approximately -80 degrees Celsius for future analyses. All samples taken during this study&#xD;
      will be made anonymous. Samples obtained during this study will be used for future ethically&#xD;
      approved studies. Participants will be made aware of this in the participant information&#xD;
      sheet prior to the process of written informed consent.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive patients for this study will be identified in a secondary care setting from&#xD;
        hypertension clinics at Cambridge University Hospitals, from two on-going observational&#xD;
        community-based cohort studies - CLEAREST and ACCT, in addition to potential participants&#xD;
        (healthy volunteers) who respond to recruitment posters displayed around Cambridge&#xD;
        University Hospitals and the University of Cambridge.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, aged 18 or above&#xD;
&#xD;
          -  Able to give informed consent and willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current active malignancy&#xD;
&#xD;
          -  Currently receiving dialysis&#xD;
&#xD;
          -  Any illness with a life expectancy &lt; 1 year&#xD;
&#xD;
          -  Lack of written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmel McEniery, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cambridge</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie Byrne</last_name>
    <phone>01223 349762</phone>
    <email>natalie.byrne@addenbrookes.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carmel McEniery, PhD</last_name>
    <phone>01223 217564</phone>
    <email>cmm41@medschl.cam.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vascular Research Clinic, Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmel McEniery, PhD</last_name>
      <email>cmm41@medschl.cam.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Carmel McEniery, MPhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 21, 2022</last_update_submitted>
  <last_update_submitted_qc>August 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Carmel McEniery</investigator_full_name>
    <investigator_title>Senior Research Associate</investigator_title>
  </responsible_party>
  <keyword>Epidemiology</keyword>
  <keyword>Ethnicity</keyword>
  <keyword>Age</keyword>
  <keyword>Weight</keyword>
  <keyword>Hypertensive</keyword>
  <keyword>Cardiac Output</keyword>
  <keyword>Peripheral Vascular Resistance</keyword>
  <keyword>Arterial Stiffness</keyword>
  <keyword>Healthy Volunteers</keyword>
  <keyword>Endothelial function</keyword>
  <keyword>Arterial Structure</keyword>
  <keyword>Left ventricular mass/function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_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/NCT03014791
org study id: AWE
nct id: NCT03014791
lead sponsor: 
collaborator: 
has dmc: No
Hypertension, also known as high blood pressure, is a chronic medical condition, in which the
      blood pressure is elevated. This is a common condition, which can lead to severe
      complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not
      detected and treated early.

      Accumulating evidence suggests that the incidence of hypertension varies according to age,
      ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological
      mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates
      of elevated blood pressure across the adult age-span, and determine the extent to which body
      size and ethnicity impact on these associations. We also wish to investigate the impact of
      hypertension on key target organs (end-organ damage). The primary objective of this study is
      to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive
      participants across the adult age span, and to assess the influence of body mass index and
      ethnic background on these mechanisms. Secondary objectives are to investigate the
      association between blood pressure and cardiovascular physiology across the adult age span at
      rest and during sub-maximal exercise and to investigate the impact of blood pressure
      haemodynamics on key organs including the arteries and heart by assessing end-organ damage
      such as endothelial function, arterial structure and left ventricular mass/function.

      This study will be a combined case-control and cross-sectional study describing the
      procedures and time commitment required to investigate our scientific aims. This is a single
      centre study that will be conducted in a secondary care environment. Both male and females
      aged 18 and over and that are able provide informed consent will be considered for this
      study. People who are pregnant, currently receiving dialysis, illness with a life expectancy
      <1 year, current active malignancy and cannot provide informed consent are ineligible for
      this study. The study will be open for five years and each patient will complete a maximum of
      four visits in a 12 month period. Participants will complete a variety of non-invasive
      physiological assessments of their cardiovascular system and lung function. There will be
      some minimally invasive procedures completed, including a blood test and assessment of small
      artery endothelial function which involves insertion of a small needle under local
      anesthetic.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Cardiac Output (Measured by the inert gas re-breathing technique L/Min)
time frame: 5 years
measure: Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )
time frame: 5 years
measure: Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)
time frame: 5 years
arm group label: Healthy Volunteers
description: No IMP to be administered, only challenge agents as part of the physiological assessments.
Large artery endothelial function:
Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)
Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)
Forearm blood flow
Acetylcholine: 7.5μg/min, 15μg/min and 30μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)
Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)
LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)
arm group label: Hypertensive Patients (Case-control)
description: No IMP to be administered, only challenge agents as part of the physiological assessments.
Large artery endothelial function:
Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)
Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)
Forearm blood flow
Acetylcholine: 7.5μg/min, 15μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)
Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)
LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)
arm group label: Hypertensive Patients (Cross-sectional)
description: No IMP to be administered, only challenge agents as part of the physiological assessments.
Large artery endothelial function:
Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms
Forearm blood flow Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms
Recruited from community-based cohort studies - CLEAREST and ACCT
Equal recruitment across the following parameters:
Age: 3 groups <30, 30-60, >60 years
Gender
BMI: 3 groups <25, 25-30, >30 Kg/m2
intervention type: Other
intervention name: Brief lifestyle/medical history questionnaire
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Anthropometric measures
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Blood pressure and arterial stiffness
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Cardiac output and lung function
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Heart rate variability
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Blood sample & spot urine sample
description: Core Measurement
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: 24 hour ambulatory blood pressure monitor
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: 24 hour urine collection
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Echocardiograph: Left ventricular mass
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Large artery structure: Carotid intima-media thickness
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Small artery structure: Minimum forearm vascular resistance
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Large artery endothelial function
description: Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Small artery endothelial function: Forearm blood flow
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Dundee step test
description: Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Detailed haemodynamic response to submaximal exercise
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Cardiopulmonary fitness: Maximum oxygen consumption
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Haemodynamic response to mental stress
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
intervention type: Other
intervention name: Small artery dilatory function: Forearm blood flow
description: Detailed Measurement (Optional for participants).
arm group label: Healthy Volunteers
arm group label: Hypertensive Patients (Case-control)
arm group label: Hypertensive Patients (Cross-sectional)
During the study, the blood and urine samples will be stored by the research team at the
      department of Experimental Medicine and Immunotherapeutics, Division of Cardiovascular
      Medicine under the responsibility of the CI who will ensure the security and confidentiality
      of the stored material. These samples will not be accessible to any investigator outside the
      research team. A small aliquot of the participant's blood and urine sample will be stored at
      approximately -80 degrees Celsius for future analyses. All samples taken during this study
      will be made anonymous. Samples obtained during this study will be used for future ethically
      approved studies. Participants will be made aware of this in the participant information
      sheet prior to the process of written informed consent.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carmel McEniery, PhD
role: Principal Investigator
affiliation: University of Cambridge
last name: Natalie Byrne
phone: 01223 349762
email: natalie.byrne@addenbrookes.nhs.uk
last name: Carmel McEniery, PhD
phone: 01223 217564
email: cmm41@medschl.cam.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Carmel McEniery
investigator title: Senior Research Associate
mesh term: Cardiovascular Diseases
mesh term: Vascular Diseases
sharing ipd: No