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/NCT05996302</url>
    </required_header>
    <id_info>
      <org_study_id>PVD_HAvsLA_6MWD</org_study_id>
      <nct_id>NCT05996302</nct_id>
    </id_info>
    <brief_title>HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)</brief_title>
    <official_title>Comparative Study of 6-minute Walk Distance (6MWD) in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level.</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>
        To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients&#xD;
        with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic&#xD;
        thromboembolic pulmonary hypertension (PH) who permanently live &gt;2500m on 6-minute walk&#xD;
        distance (6MWD)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research in patients with PVD diagnosed with precapillary PH with right heart&#xD;
        catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA&#xD;
        &gt;2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m&#xD;
        and at sea level in Pedernales the day after the first and the second night after relocation.&#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>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Patients living permanently &gt;2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6-minute walk distance (6MWD) after the first night at LA</measure>
      <time_frame>after the first night at LA (sea level)</time_frame>
      <description>Change in 6MWD in meter between LA (sea level) vs HA (2840 m)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6-minute walk distance (6MWD) after the second night at LA</measure>
      <time_frame>after the second night at LA (sea level)</time_frame>
      <description>Change in 6MWD in meter between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA</measure>
      <time_frame>after the first night at LA (sea level)</time_frame>
      <description>Change in SpO2 in % between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA</measure>
      <time_frame>after the second night at LA (sea level)</time_frame>
      <description>Change in SpO2 in % between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate at rest and at peak 6MWD after the first night at LA</measure>
      <time_frame>after the first night at LA (sea level)</time_frame>
      <description>Change in heart rate in bpm between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate at rest and at peak 6MWD after the second night at LA</measure>
      <time_frame>after the second night at LA (sea level)</time_frame>
      <description>Change in heart rate in bpm between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure at rest and at peak 6MWD after the first night at LA</measure>
      <time_frame>after the first night at LA (sea level)</time_frame>
      <description>Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure at rest and at peak 6MWD after the second night at LA</measure>
      <time_frame>after the second night at LA (sea level)</time_frame>
      <description>Change in blood pressure in mmHg between LA (sea level) vs HA (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>6-minute walk distance at 2840m</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m</description>
    </arm_group>
    <arm_group>
      <arm_group_label>6-minute walk distance at sea level</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Relocation to sea level</intervention_name>
      <description>Relocation to sea level by bus and stay for 2 days</description>
      <arm_group_label>6-minute walk distance at 2840m</arm_group_label>
      <arm_group_label>6-minute walk distance at sea level</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion 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 WU (wood units) by right heart catheterization) with PH being classified as&#xD;
               PAH or CTEPH according to guidelines&#xD;
  &#xD;
            -  Patients stable on therapy&#xD;
  &#xD;
            -  NYHA (new york heart association) 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 igarettes/day)&#xD;
  &#xD;
            -  Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen&#xD;
               saturation by pulseoximetry) &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 Zurich</name>
        <address>
          <city>Zurich</city>
          <zip>8091</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Ulrich, MD</last_name>
        <phone>0041442554362</phone>
        <email>silvia.ulrich@usz.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary Hypertension</keyword>
    <keyword>Hypoxia</keyword>
    <keyword>6-minute walk test</keyword>
    <keyword>High altitude</keyword>
    <keyword>Pulmonary Artery Hypertension</keyword>
    <keyword>Chronic Thromboembolic Pulmonary Hypertension</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/NCT05996302
  org study id: PVD_HAvsLA_6MWD
  nct id: NCT05996302
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients
        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)
  This research in patients 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
        and at sea level in Pedernales the day after the first and the second night after relocation.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: Patients living permanently >2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: 6-minute walk distance (6MWD) after the first night at LA
  time frame: after the first night at LA (sea level)
  description: Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
  measure: 6-minute walk distance (6MWD) after the second night at LA
  time frame: after the second night at LA (sea level)
  description: Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
  measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA
  time frame: after the first night at LA (sea level)
  description: Change in SpO2 in % between LA (sea level) vs HA (2840 m)
  measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA
  time frame: after the second night at LA (sea level)
  description: Change in SpO2 in % between LA (sea level) vs HA (2840 m)
  measure: Heart rate at rest and at peak 6MWD after the first night at LA
  time frame: after the first night at LA (sea level)
  description: Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
  measure: Heart rate at rest and at peak 6MWD after the second night at LA
  time frame: after the second night at LA (sea level)
  description: Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
  measure: Blood pressure at rest and at peak 6MWD after the first night at LA
  time frame: after the first night at LA (sea level)
  description: Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
  measure: Blood pressure at rest and at peak 6MWD after the second night at LA
  time frame: after the second night at LA (sea level)
  description: Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
  arm group label: 6-minute walk distance at 2840m
  arm group type: Active Comparator
  description: Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m
  arm group label: 6-minute walk distance at sea level
  arm group type: Experimental
  description: Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)
  intervention type: Behavioral
  intervention name: Relocation to sea level
  description: Relocation to sea level by bus and stay for 2 days
  arm group label: 6-minute walk distance at 2840m
  arm group label: 6-minute walk distance at sea level
  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: 
  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.