xml: <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/NCT05963880</url>
    </required_header>
    <id_info>
      <org_study_id>CBP-REIN</org_study_id>
      <nct_id>NCT05963880</nct_id>
    </id_info>
    <brief_title>Concordance Between Central Blood PRessure dEvices In Nephrology Patients</brief_title>
    <acronym>CBP-REIN</acronym>
    <official_title>Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal</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 most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular&#xD;
        catheterization, which is not possible to perform routinely during the regular follow-up of&#xD;
        patients. However, in recent years, devices used to estimate central BP have been designed&#xD;
        and approved for clinical use. These devices can determine aortic BP in a non-invasive way&#xD;
        using various techniques and algorithms and offer a high degree of precision when compared to&#xD;
        invasive measurements of intraaortic BP. On the other hand, certain characteristics specific&#xD;
        to the different devices mean that the central BP values obtained may not be interchangeable.&#xD;
        It is therefore important to determine the degree of agreement of central BP values obtained&#xD;
        using commercially available devices.&#xD;
  &#xD;
        This study aims to determine the degree of agreement between central BP measurements obtained&#xD;
        using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM,&#xD;
        Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA)&#xD;
        and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and&#xD;
        then derive the central BP using an algorithm. The main differences between these devices lie&#xD;
        in this algorithm, or &quot;transfer function,&quot;, which is unique to each and the calibration used.&#xD;
        All use a brachial cuff to capture the pulse waveform and can easily be used in clinical&#xD;
        practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 26, 2021</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Central SBP difference</measure>
      <time_frame>at enrollment (time 0)</time_frame>
      <description>Differences in the central SBP measured by each device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Brachial SBP difference</measure>
      <time_frame>at enrollment (time 0)</time_frame>
      <description>Differences in the brachial cuff SBP measured by each device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Central DBP difference</measure>
      <time_frame>at enrollment (time 0)</time_frame>
      <description>Differences in the central DBP measured by each device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brachial DBP difference</measure>
      <time_frame>at enrollment (time 0)</time_frame>
      <description>Differences in the brachial cuff DBP measured by each device</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">340</enrollment>
    <condition>Hypertension</condition>
    <condition>Chronic Kidney Disease</condition>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>Advanced CKD group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with eGFR &lt; 30 ml/min/1.73m2 not on dialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dialysis groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients on hemodialysis or peritoneal dialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hypertension group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with BP &gt; 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR &gt; 60 ml/min/1.73m2)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Normotensive patients without any antihypertensive drugs or chronic kidney disease</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech)</intervention_name>
      <description>All participants will have three readings at 1-min interval after a 5-min seated rest with each device. The order in which each device will be tested is randomized.</description>
      <arm_group_label>Advanced CKD group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Dialysis groups</arm_group_label>
      <arm_group_label>Hypertension group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Age 18-80 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ongoing atrial fibrillation&#xD;
  &#xD;
            -  Arm circumference incompatible with the blood pressure cuffs for all devices (&lt;18 cm&#xD;
               or &gt; 50 cm)&#xD;
  &#xD;
            -  Incapacity to give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Remi Goupil, MD MSc</last_name>
      <phone>1-514-338-2883</phone>
      <email>remi.goupil@umontreal.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital du Sacré-Coeur de Montréal</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4J1C5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guylaine Marcotte</last_name>
      </contact>
      <investigator>
        <last_name>Remi Goupil, MD MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>central blood pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963880
  org study id: CBP-REIN
  nct id: NCT05963880
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular
        catheterization, which is not possible to perform routinely during the regular follow-up of
        patients. However, in recent years, devices used to estimate central BP have been designed
        and approved for clinical use. These devices can determine aortic BP in a non-invasive way
        using various techniques and algorithms and offer a high degree of precision when compared to
        invasive measurements of intraaortic BP. On the other hand, certain characteristics specific
        to the different devices mean that the central BP values obtained may not be interchangeable.
        It is therefore important to determine the degree of agreement of central BP values obtained
        using commercially available devices.
  
        This study aims to determine the degree of agreement between central BP measurements obtained
        using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM,
        Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA)
        and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and
        then derive the central BP using an algorithm. The main differences between these devices lie
        in this algorithm, or "transfer function,", which is unique to each and the calibration used.
        All use a brachial cuff to capture the pulse waveform and can easily be used in clinical
        practice.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Central SBP difference
  time frame: at enrollment (time 0)
  description: Differences in the central SBP measured by each device
  measure: Brachial SBP difference
  time frame: at enrollment (time 0)
  description: Differences in the brachial cuff SBP measured by each device
  measure: Central DBP difference
  time frame: at enrollment (time 0)
  description: Differences in the central DBP measured by each device
  measure: Brachial DBP difference
  time frame: at enrollment (time 0)
  description: Differences in the brachial cuff DBP measured by each device
  arm group label: Advanced CKD group
  arm group type: Experimental
  description: Patients with eGFR < 30 ml/min/1.73m2 not on dialysis
  arm group label: Dialysis groups
  arm group type: Experimental
  description: Patients on hemodialysis or peritoneal dialysis
  arm group label: Hypertension group
  arm group type: Experimental
  description: Patients with BP > 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR > 60 ml/min/1.73m2)
  arm group label: Control group
  arm group type: Active Comparator
  description: Normotensive patients without any antihypertensive drugs or chronic kidney disease
  intervention type: Device
  intervention name: Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech)
  description: All participants will have three readings at 1-min interval after a 5-min seated rest with each device. The order in which each device will be tested is randomized.
  arm group label: Advanced CKD group
  arm group label: Control group
  arm group label: Dialysis groups
  arm group label: Hypertension group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Remi Goupil, MD MSc
  phone: 1-514-338-2883
  email: remi.goupil@umontreal.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic