<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/NCT03267420</url>
  </required_header>
  <id_info>
    <org_study_id>6486</org_study_id>
    <nct_id>NCT03267420</nct_id>
  </id_info>
  <brief_title>Blood Pressure Measurement: Should Technique Define Targets?</brief_title>
  <official_title>Blood Pressure Measurement: Should Technique Define Targets?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Physicians' Services Incorporated Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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>
      Hypertension is the single most important risk factor for cardiovascular disease and death,&#xD;
      yet blood pressure itself is highly influenced by technique and device. Hence, the target&#xD;
      blood pressure could vary materially based on BP technique and device used. In the present&#xD;
      study, the investigators will compare 4 different methods of measuring blood pressure in the&#xD;
      office (casual, resting average of 3 readings with nurse present or absent for resting&#xD;
      period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results&#xD;
      of this study will help and enable practicing family physicians and specialists in Canada to&#xD;
      target BP for their patients based on algorithm and method of assessment of BP they use in&#xD;
      their offices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension is the single most important risk factor for cardiovascular disease and death.&#xD;
      Over the last several decades many classes of blood pressure lowering drugs have been&#xD;
      discovered. These allow physicians to achieve optimal blood pressure and prevent adverse&#xD;
      cardiovascular outcomes in most patients. However, the optimal blood pressure level has&#xD;
      changed over time, and most recently has been decreased to 120 mm Hg, on the basis of&#xD;
      clinical trials. These trials used a specific rigorous method of blood pressure measurement&#xD;
      (patient alone in room, enforced period of rest, average of multiple readings) that is&#xD;
      currently not the standard of practice in most clinics. Blood pressure itself is highly&#xD;
      influenced by technique and device. In particular the length of resting time (if any), and&#xD;
      whether it is measured with device requiring medical personnel presence in the room or not.&#xD;
      For the same individual, the difference between blood pressure taken with and without rest&#xD;
      could be 10 mmHg, and presence vs absence of medical personnel in the room during rest and/or&#xD;
      BP assessment could be another 10 mmHg. Hence, the target blood pressure could vary&#xD;
      materially based on BP technique and device used. As it is unlikely that all physicians can&#xD;
      change their practice overnight and embrace blood pressure device allowing for standard&#xD;
      resting time and unattended blood assessment, a comparative pragmatic study of the blood&#xD;
      pressure technique and devices endorsed by Hypertension Canada and used in Canada is&#xD;
      desirable to avoid either over- or under-treatment of Canadian patients with hypertension.&#xD;
&#xD;
      In the present study, the investigators will compare 4 different methods of measuring blood&#xD;
      pressure in the office (casual, resting average of 3 readings with nurse present or absent&#xD;
      for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement in&#xD;
      90 patients. The results of this study will help and enable practicing family physicians and&#xD;
      specialists in Canada to target BP for their patients based on algorithm and method of&#xD;
      assessment of BP they use in their offices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Casual Blood Pressure versus Omron HEM 907XL unattended</measure>
    <time_frame>24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)</time_frame>
    <description>The effect of unattended 5-minute rest preceding unattended systolic blood pressure assessment will be derived from the difference between casual blood pressure (measured in mm Hg) and average resting unattended systolic blood pressure (measured in mm Hg) as measured with the Omron HEM 907 XL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BpTRU versus Omron HEM 907XL with 5 minutes unattended rest</measure>
    <time_frame>24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)</time_frame>
    <description>The difference between average systolic blood pressure measured with BpTRU and Omron HEM907XL (both measured in mm Hg) will allow us to report the effect of the additional five minutes of rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Omron HEM 907XL unattended versus Omron HEM 907XL partially attended</measure>
    <time_frame>24 hours: from Visit 1 and Visit 2 (group 3)</time_frame>
    <description>Difference between systolic blood pressure between the two visits in Group 3 will address an issue of unattended versus partially attended resting systolic blood pressure (both measured in mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Omron HEM 907XL unattended versus ABPM device</measure>
    <time_frame>24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)</time_frame>
    <description>Difference between the average unattended systolic blood pressure and daytime average blood pressure from the 24 hour ABPM</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>BpTRU First, Unattended Omron Second</intervention_name>
    <description>Visit 1: The participants will have the oscillometric device, BpTRU applied to their arm with the higher blood pressure. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended readings. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.&#xD;
Visit 2: Upon returning the 24 hour ABPM device, the patient will have their blood pressure measured with an unattended Omron second. The Omron HEM 907XL will be applied to the same arm that the BpTRU was applied to in the first visit. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Unattended Omron First, BpTRU Second</intervention_name>
    <description>Visit 1: The participants will have the Omron HEM 907XL will be applied to their arm with the higher blood pressure. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.&#xD;
Visit 2: Upon returning the 24 hour ABPM device, the participants will have the oscillometric device, BpTRU applied to the same arm that the Omron HEM 907 XL was applied to in the first visit. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended blood pressure readings.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Partially Attended Omron First, Unattended Omron Second</intervention_name>
    <description>Visit 1: The participant will have the Omron HEM 907 XL applied to the arm with the higher blood pressure. There will be five minutes of quiet rest (patient alone) and three reading subsequently, but with the nurse entering the room (i.e., partially attended), with the average being noted. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.&#xD;
Visit 2: Upon returning 24 hour ABPM device, the participant will have the Omron HEM 907 XL applied to same arm that was used during the first visit. There will be five minutes of quiet rest (patient alone) and three readings subsequently (patient still alone) with the average blood pressure measurement being noted.</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients being followed in the Renal Hypertension Clinic will be eligible for&#xD;
             enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)&#xD;
&#xD;
          -  inability to consent the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcel Ruzicka, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hypertension Unit of The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03267420/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03267420
org study id: 6486
nct id: NCT03267420
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertension is the single most important risk factor for cardiovascular disease and death,
      yet blood pressure itself is highly influenced by technique and device. Hence, the target
      blood pressure could vary materially based on BP technique and device used. In the present
      study, the investigators will compare 4 different methods of measuring blood pressure in the
      office (casual, resting average of 3 readings with nurse present or absent for resting
      period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results
      of this study will help and enable practicing family physicians and specialists in Canada to
      target BP for their patients based on algorithm and method of assessment of BP they use in
      their offices.
Hypertension is the single most important risk factor for cardiovascular disease and death.
      Over the last several decades many classes of blood pressure lowering drugs have been
      discovered. These allow physicians to achieve optimal blood pressure and prevent adverse
      cardiovascular outcomes in most patients. However, the optimal blood pressure level has
      changed over time, and most recently has been decreased to 120 mm Hg, on the basis of
      clinical trials. These trials used a specific rigorous method of blood pressure measurement
      (patient alone in room, enforced period of rest, average of multiple readings) that is
      currently not the standard of practice in most clinics. Blood pressure itself is highly
      influenced by technique and device. In particular the length of resting time (if any), and
      whether it is measured with device requiring medical personnel presence in the room or not.
      For the same individual, the difference between blood pressure taken with and without rest
      could be 10 mmHg, and presence vs absence of medical personnel in the room during rest and/or
      BP assessment could be another 10 mmHg. Hence, the target blood pressure could vary
      materially based on BP technique and device used. As it is unlikely that all physicians can
      change their practice overnight and embrace blood pressure device allowing for standard
      resting time and unattended blood assessment, a comparative pragmatic study of the blood
      pressure technique and devices endorsed by Hypertension Canada and used in Canada is
      desirable to avoid either over- or under-treatment of Canadian patients with hypertension.

      In the present study, the investigators will compare 4 different methods of measuring blood
      pressure in the office (casual, resting average of 3 readings with nurse present or absent
      for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement in
      90 patients. The results of this study will help and enable practicing family physicians and
      specialists in Canada to target BP for their patients based on algorithm and method of
      assessment of BP they use in their offices.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Casual Blood Pressure versus Omron HEM 907XL unattended
time frame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
description: The effect of unattended 5-minute rest preceding unattended systolic blood pressure assessment will be derived from the difference between casual blood pressure (measured in mm Hg) and average resting unattended systolic blood pressure (measured in mm Hg) as measured with the Omron HEM 907 XL
measure: BpTRU versus Omron HEM 907XL with 5 minutes unattended rest
time frame: 24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)
description: The difference between average systolic blood pressure measured with BpTRU and Omron HEM907XL (both measured in mm Hg) will allow us to report the effect of the additional five minutes of rest
measure: Omron HEM 907XL unattended versus Omron HEM 907XL partially attended
time frame: 24 hours: from Visit 1 and Visit 2 (group 3)
description: Difference between systolic blood pressure between the two visits in Group 3 will address an issue of unattended versus partially attended resting systolic blood pressure (both measured in mm Hg)
measure: Omron HEM 907XL unattended versus ABPM device
time frame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
description: Difference between the average unattended systolic blood pressure and daytime average blood pressure from the 24 hour ABPM
arm group label: Group 1
arm group type: Experimental
description: A group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure.
arm group label: Group 2
arm group type: Active Comparator
description: A group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure.
arm group label: Group 3
arm group type: Active Comparator
description: A group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure.
intervention type: Diagnostic Test
intervention name: BpTRU First, Unattended Omron Second
description: Visit 1: The participants will have the oscillometric device, BpTRU applied to their arm with the higher blood pressure. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended readings. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
Visit 2: Upon returning the 24 hour ABPM device, the patient will have their blood pressure measured with an unattended Omron second. The Omron HEM 907XL will be applied to the same arm that the BpTRU was applied to in the first visit. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.
arm group label: Group 1
intervention type: Diagnostic Test
intervention name: Unattended Omron First, BpTRU Second
description: Visit 1: The participants will have the Omron HEM 907XL will be applied to their arm with the higher blood pressure. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
Visit 2: Upon returning the 24 hour ABPM device, the participants will have the oscillometric device, BpTRU applied to the same arm that the Omron HEM 907 XL was applied to in the first visit. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended blood pressure readings.
arm group label: Group 2
intervention type: Diagnostic Test
intervention name: Partially Attended Omron First, Unattended Omron Second
description: Visit 1: The participant will have the Omron HEM 907 XL applied to the arm with the higher blood pressure. There will be five minutes of quiet rest (patient alone) and three reading subsequently, but with the nurse entering the room (i.e., partially attended), with the average being noted. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
Visit 2: Upon returning 24 hour ABPM device, the participant will have the Omron HEM 907 XL applied to same arm that was used during the first visit. There will be five minutes of quiet rest (patient alone) and three readings subsequently (patient still alone) with the average blood pressure measurement being noted.
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcel Ruzicka, MD, PHD
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
provided document: 