<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/NCT04409847</url>
  </required_header>
  <id_info>
    <org_study_id>GN20CA245</org_study_id>
    <nct_id>NCT04409847</nct_id>
  </id_info>
  <brief_title>COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)</brief_title>
  <acronym>OBELIX</acronym>
  <official_title>COVID-19 Blood Pressure Endothelium Interaction Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</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>
      The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical&#xD;
      challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ&#xD;
      systems, including the cardiovascular system. There are documented associations between&#xD;
      severity of disease and risk of death and To provide all the information required by review&#xD;
      bodies and research information systems, we ask a number of specific questions. This section&#xD;
      invites you to give an overview using language comprehensible to lay reviewers and members of&#xD;
      the public. Please read the guidance notes for advice on this section.&#xD;
&#xD;
      5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated&#xD;
      comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer).&#xD;
      The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart&#xD;
      failure, pulmonary embolism and disseminated intravascular coagulation.&#xD;
&#xD;
      It is thought that the mechanism of action of the virus involves binding to a host&#xD;
      transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and&#xD;
      immune cells and cause further damage. While ACE2 is essential for viral invasion, it is&#xD;
      unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin&#xD;
      receptor blockers (ARBs) alter prognosis.&#xD;
&#xD;
      This study aims to look closely at the health of the vascular system of patients after being&#xD;
      treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had&#xD;
      a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study&#xD;
      is essential so that clinicians treating patients with high blood pressure understand the&#xD;
      impact of the condition and these hypertension medicines in the context of the current&#xD;
      COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients&#xD;
      currently prescribed these medications or who are newly diagnosed with hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 is pandemic and, though it primarily affects the lungs, there is evidence of&#xD;
      cardiovascular system involvement. Mechanistically, SARS-CoV-2, following proteolytic&#xD;
      cleavage of its S protein by a serine protease, binds to the transmembrane&#xD;
      angiotensin-converting enzyme 2 (ACE2) -a homologue of ACE-to enter type 2 pneumocytes,&#xD;
      macrophages, perivascular pericytes, and cardiomyocytes. This may lead to myocardial&#xD;
      dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque&#xD;
      instability, and myocardial infarction. While ACE2 is essential for viral invasion, it is&#xD;
      unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin&#xD;
      receptor blockers alter prognosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>ABPM systolic blood pressure</measure>
    <time_frame>24 hours (all day and night)</time_frame>
    <description>Ambulatory Blood Pressure Monitoring systolic blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hr ABPM DBP</measure>
    <time_frame>24 hours (all day and night)</time_frame>
    <description>Ambulatory Blood Pressure Monitoring diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>day ABPM SBP</measure>
    <time_frame>8am to 8pm</time_frame>
    <description>Day Ambulatory Blood Pressure Monitoring systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>day ABPM DBP</measure>
    <time_frame>8am to 8pm</time_frame>
    <description>Day Ambulatory Blood Pressure Monitoring diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>night ABPM SBP</measure>
    <time_frame>8pm to 8am</time_frame>
    <description>Night Ambulatory Blood Pressure Monitoring systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>night ABPM DBP</measure>
    <time_frame>8pm to 8am</time_frame>
    <description>Night Ambulatory Blood Pressure Monitoring diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dipping status</measure>
    <time_frame>24 hours (all day and night)</time_frame>
    <description>The fall in pressure, called the &quot;dip&quot;, is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morning surge</measure>
    <time_frame>24 hours (all day and night)</time_frame>
    <description>he morning surge was defined as the difference between the mean systolic blood pressure during the 2 hours after waking and arising minus the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour ABPM HR</measure>
    <time_frame>24hr (all day and night)</time_frame>
    <description>24 hour Ambulatory Blood Pressure Monitoring heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>day ABPM HR</measure>
    <time_frame>8 am to 8 pm</time_frame>
    <description>Day Ambulatory Blood Pressure Monitoring heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>night ABPM HR</measure>
    <time_frame>8pm to 8 am</time_frame>
    <description>Night Ambulatory Blood Pressure Monitoring heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune phenotyping</measure>
    <time_frame>at baseline</time_frame>
    <description>Immune phenotyping includes cellular and humoral markers of immune cell activation and senescence within populations of key leukocyte subsets e.g. lymphocytes and monocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microparticle assessments</measure>
    <time_frame>at baseline</time_frame>
    <description>microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>COVID</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <description>Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID- PCR</arm_group_label>
    <description>subjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ABPM</intervention_name>
    <description>24 hour ambulatory blood pressure monitoring</description>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <arm_group_label>COVID- PCR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ECG</intervention_name>
    <description>Electrocardiogram</description>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <arm_group_label>COVID- PCR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FMD</intervention_name>
    <description>Flow mediated dilatation</description>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <arm_group_label>COVID- PCR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PWV</intervention_name>
    <description>Pulse wave velocity</description>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <arm_group_label>COVID- PCR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rarefaction</intervention_name>
    <description>nailbed capillaroscopy</description>
    <arm_group_label>COVID+ PCR</arm_group_label>
    <arm_group_label>COVID- PCR</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood and urine samples for vascular phenotpying marker, immuno phenotyping markers and&#xD;
      future biomarker studies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted through QEUH immediate assessment unit and acute receiving units with&#xD;
        suspected or confirmed COVID-19 during 01/04/20 - 31/12/20 and who are alive at discharge.&#xD;
        Clinically suspected COVID-19 should have at least two of the following presenting features&#xD;
        (fever, new onset cough, fatigue, myalgia, breathlessness, GI symptoms, anosmia/dysgeusia,&#xD;
        contact with known COVID-19 positive patient).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission between 01/04/2020 and 31/12/2020 Clinically suspected or PCR confirmed&#xD;
             COVID-19 Age 30-60 years No history of hypertension or current drug treatment for&#xD;
             hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent/lack of capacity Non-English speakers BMI &gt;40 eGFR&#xD;
             &lt;60 ml/min Pregnancy History of Cancer within 5 years Persistent atrial fibrillation&#xD;
             Severe illness, at investigator discretion Prescription of BP lowering drugs&#xD;
             Corticosteroid (chronic use) Immunosupressive agents NSAIDs (chronic use)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katriona Brooksbank</last_name>
    <phone>01413302418</phone>
    <email>katriona.brooksbank@glasgow.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rhian M Touyz</last_name>
    <phone>01413307775</phone>
    <email>rhian.touyz@glasgow.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04409847
org study id: GN20CA245
nct id: NCT04409847
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical
      challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ
      systems, including the cardiovascular system. There are documented associations between
      severity of disease and risk of death and To provide all the information required by review
      bodies and research information systems, we ask a number of specific questions. This section
      invites you to give an overview using language comprehensible to lay reviewers and members of
      the public. Please read the guidance notes for advice on this section.

      5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated
      comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer).
      The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart
      failure, pulmonary embolism and disseminated intravascular coagulation.

      It is thought that the mechanism of action of the virus involves binding to a host
      transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and
      immune cells and cause further damage. While ACE2 is essential for viral invasion, it is
      unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin
      receptor blockers (ARBs) alter prognosis.

      This study aims to look closely at the health of the vascular system of patients after being
      treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had
      a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study
      is essential so that clinicians treating patients with high blood pressure understand the
      impact of the condition and these hypertension medicines in the context of the current
      COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients
      currently prescribed these medications or who are newly diagnosed with hypertension.
COVID-19 is pandemic and, though it primarily affects the lungs, there is evidence of
      cardiovascular system involvement. Mechanistically, SARS-CoV-2, following proteolytic
      cleavage of its S protein by a serine protease, binds to the transmembrane
      angiotensin-converting enzyme 2 (ACE2) -a homologue of ACE-to enter type 2 pneumocytes,
      macrophages, perivascular pericytes, and cardiomyocytes. This may lead to myocardial
      dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque
      instability, and myocardial infarction. While ACE2 is essential for viral invasion, it is
      unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin
      receptor blockers alter prognosis.
observational model: Cohort
time perspective: Prospective
measure: ABPM systolic blood pressure
time frame: 24 hours (all day and night)
description: Ambulatory Blood Pressure Monitoring systolic blood pressure
measure: 24-hr ABPM DBP
time frame: 24 hours (all day and night)
description: Ambulatory Blood Pressure Monitoring diastolic blood pressure
measure: day ABPM SBP
time frame: 8am to 8pm
description: Day Ambulatory Blood Pressure Monitoring systolic blood pressure
measure: day ABPM DBP
time frame: 8am to 8pm
description: Day Ambulatory Blood Pressure Monitoring diastolic blood pressure
measure: night ABPM SBP
time frame: 8pm to 8am
description: Night Ambulatory Blood Pressure Monitoring systolic blood pressure
measure: night ABPM DBP
time frame: 8pm to 8am
description: Night Ambulatory Blood Pressure Monitoring diastolic blood pressure
measure: dipping status
time frame: 24 hours (all day and night)
description: The fall in pressure, called the "dip", is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value
measure: morning surge
time frame: 24 hours (all day and night)
description: he morning surge was defined as the difference between the mean systolic blood pressure during the 2 hours after waking and arising minus the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep.
measure: 24 hour ABPM HR
time frame: 24hr (all day and night)
description: 24 hour Ambulatory Blood Pressure Monitoring heart rate
measure: day ABPM HR
time frame: 8 am to 8 pm
description: Day Ambulatory Blood Pressure Monitoring heart rate
measure: night ABPM HR
time frame: 8pm to 8 am
description: Night Ambulatory Blood Pressure Monitoring heart rate
measure: Immune phenotyping
time frame: at baseline
description: Immune phenotyping includes cellular and humoral markers of immune cell activation and senescence within populations of key leukocyte subsets e.g. lymphocytes and monocytes
measure: Microparticle assessments
time frame: at baseline
description: microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction
arm group label: COVID+ PCR
description: Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19
arm group label: COVID- PCR
description: subjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group
intervention type: Diagnostic Test
intervention name: ABPM
description: 24 hour ambulatory blood pressure monitoring
arm group label: COVID+ PCR
arm group label: COVID- PCR
intervention type: Diagnostic Test
intervention name: ECG
description: Electrocardiogram
arm group label: COVID+ PCR
arm group label: COVID- PCR
intervention type: Diagnostic Test
intervention name: FMD
description: Flow mediated dilatation
arm group label: COVID+ PCR
arm group label: COVID- PCR
intervention type: Diagnostic Test
intervention name: PWV
description: Pulse wave velocity
arm group label: COVID+ PCR
arm group label: COVID- PCR
intervention type: Diagnostic Test
intervention name: Rarefaction
description: nailbed capillaroscopy
arm group label: COVID+ PCR
arm group label: COVID- PCR
blood and urine samples for vascular phenotpying marker, immuno phenotyping markers and
      future biomarker studies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Katriona Brooksbank
phone: 01413302418
email: katriona.brooksbank@glasgow.ac.uk
last name: Rhian M Touyz
phone: 01413307775
email: rhian.touyz@glasgow.ac.uk
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Undecided