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/NCT06003244</url>
    </required_header>
    <id_info>
      <org_study_id>PVD_HA_SOT_6MWD</org_study_id>
      <nct_id>NCT06003244</nct_id>
    </id_info>
    <brief_title>HA Residents With PVD, 6MWD Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)</brief_title>
    <official_title>Effect of Supplemental Oxygen Therapy (SOT) in Patients With Pulmonary Vascular Diseases (PVD) Defined as Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension (PH) Who Permanently Live &gt;2500m on 6-minute Walk Distance (6MWD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Zurich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Zurich</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 investigators aim to study the effect of SOT in participants with pulmonary vascular&#xD;
        diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary&#xD;
        hypertension (PH) who permanently live &gt;2500m on 6-minute walk distance (6MWD) assessed at&#xD;
        2840m.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants with PVD diagnosed with precapillary PH with right heart catheterization and&#xD;
        classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA &gt;2500 (PVDHA) will&#xD;
        have 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT&#xD;
        at 3l/min via nasal cannula according to a randomized cross-over design.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Each participant works as its own perfect control</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6-minute walk distance (6MWD) with SOT vs. ambient air at 2840m</measure>
      <time_frame>after 6 minute</time_frame>
      <description>Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m</measure>
      <time_frame>6 minutes</time_frame>
      <description>Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m</measure>
      <time_frame>6 minutes</time_frame>
      <description>Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m</measure>
      <time_frame>6 minutes</time_frame>
      <description>Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m</measure>
      <time_frame>6 minutes</time_frame>
      <description>Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Pulmonary Vascular Disease</condition>
    <condition>Pulmonary Artery Hypertension</condition>
    <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
    <arm_group>
      <arm_group_label>Ambient air</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patient will perform 6MWD test on ambient air at 2840 m</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SOT via nasal canula</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>6-minute walk distance (6MWD) test</intervention_name>
      <description>6-minute walk distance (6MWD) test will be performed according to clinical standards</description>
      <arm_group_label>Ambient air</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)</intervention_name>
      <description>6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)</description>
      <arm_group_label>SOT via nasal canula</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          IInclusion Criteria:&#xD;
  &#xD;
            -  Adult patients 18-80 years old of both genders,&#xD;
  &#xD;
            -  Residence &gt; 2500m of altitude&#xD;
  &#xD;
            -  diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) &gt;20 mmHg,&#xD;
               pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance&#xD;
               (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as&#xD;
               PAH or CTEPH according to guidelines&#xD;
  &#xD;
            -  Patients stable on therapy&#xD;
  &#xD;
            -  New York Heart Association (NYHA) functional class I-III&#xD;
  &#xD;
            -  Provided written informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years or &gt;80 years&#xD;
  &#xD;
            -  unstable condition&#xD;
  &#xD;
            -  Patients who cannot follow the study investigations, patient permanently living &lt;&#xD;
               2500m.&#xD;
  &#xD;
            -  Patients with moderate to severe concomitant lung disease (FEV1&lt;70% or forced vital&#xD;
               capacity &lt;70%), severe parenchymal lung disease, severe smokers (&gt;20 cigarettes/day)&#xD;
  &#xD;
            -  Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by&#xD;
               pulseoximetry (SpO2) &lt;80% on ambient air.&#xD;
  &#xD;
            -  Patients with chronic mountain sickness (Hemoglobin &gt; 19 g/dl in women, &gt;21 g/dl in&#xD;
               men)&#xD;
  &#xD;
            -  Patient with a non-corrected ventricular septum defect&#xD;
  &#xD;
            -  Relevant concomitant other disease of the heart, kidney, liver, blood (anemia&#xD;
               hemoglobin&lt;11 g/dl)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvia Ulrich, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Zurich, Departement of Pulmonology</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rodrigo Hoyos, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Carlos Adrade Marin Hospital of Quito, Equador</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Silvia Ulrich, Prof. Dr.</last_name>
      <phone>+41442552220</phone>
      <email>silvia.ulrich@usz.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mona Lichtblau, Dr.</last_name>
      <phone>+41442552220</phone>
      <email>mona.lichtblau@usz.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Zürich</name>
        <address>
          <city>Zürich</city>
          <zip>8091</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Ulrich</last_name>
        <phone>+41442552220</phone>
        <email>silvia.ulrich@usz.ch</email>
      </contact>
      <contact_backup>
        <last_name>Mona Lichtblau</last_name>
        <phone>+41442552220</phone>
        <email>mona.lichtblau@usz.ch</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary Hypertension</keyword>
    <keyword>Hypoxia</keyword>
    <keyword>Supplemental Oxygen Therapy</keyword>
    <keyword>Pulmonary arterial hypertension</keyword>
    <keyword>Chronic Thromboembolic Pulmonary Hypertension</keyword>
    <keyword>High altitude</keyword>
    <keyword>Pulmonary vascular disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Vascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be provided upon request and based on a clear intention reviewed by an ethical review board.</ipd_description>
    </patient_data>
    <!-- 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/NCT06003244
  org study id: PVD_HA_SOT_6MWD
  nct id: NCT06003244
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aim to study the effect of SOT in participants with pulmonary vascular
        diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary
        hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at
        2840m.
  Participants with PVD diagnosed with precapillary PH with right heart catheterization and
        classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will
        have 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT
        at 3l/min via nasal cannula according to a randomized cross-over design.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Each participant works as its own perfect control
  primary purpose: Other
  masking: None (Open Label)
  measure: 6-minute walk distance (6MWD) with SOT vs. ambient air at 2840m
  time frame: after 6 minute
  description: Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
  measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
  time frame: 6 minutes
  description: Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
  measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
  time frame: 6 minutes
  description: Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
  measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
  time frame: 6 minutes
  description: Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
  measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
  time frame: 6 minutes
  description: Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
  arm group label: Ambient air
  arm group type: Active Comparator
  description: Patient will perform 6MWD test on ambient air at 2840 m
  arm group label: SOT via nasal canula
  arm group type: Experimental
  description: Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care
  intervention type: Other
  intervention name: 6-minute walk distance (6MWD) test
  description: 6-minute walk distance (6MWD) test will be performed according to clinical standards
  arm group label: Ambient air
  intervention type: Other
  intervention name: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
  description: 6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)
  arm group label: SOT via nasal canula
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Silvia Ulrich, Prof. Dr.
  role: Principal Investigator
  affiliation: University Hospital Zurich, Departement of Pulmonology
  last name: Rodrigo Hoyos, Dr.
  role: Principal Investigator
  affiliation: Carlos Adrade Marin Hospital of Quito, Equador
  last name: Silvia Ulrich, Prof. Dr.
  phone: +41442552220
  email: silvia.ulrich@usz.ch
  last name: Mona Lichtblau, Dr.
  phone: +41442552220
  email: mona.lichtblau@usz.ch
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Hypertension, Pulmonary
  mesh term: Pulmonary Arterial Hypertension
  mesh term: Hypertension
  mesh term: Vascular Diseases
  sharing ipd: Yes
  ipd description: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.