<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/NCT02249806</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0214_ZH PH Cohort</org_study_id>
    <nct_id>NCT02249806</nct_id>
  </id_info>
  <brief_title>Zürich Pulmonary Hypertension Outcome Assessment Cohort</brief_title>
  <acronym>ZHPHCohort</acronym>
  <official_title>Zürich Pulmonary Hypertension Outcome Assessment Cohort</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      PH is a serious disease with a dismal prognosis and impaired quality of life when left&#xD;
      untreated. Reliable patient centered and prognostically relevant outcome measures are highly&#xD;
      warranted in the field of PH. With this prospective cohort study the investigators intend to&#xD;
      gain important information on the course of the disease and knowledge on the value of&#xD;
      different new and already established outcome parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PH is a serious disease with a dismal prognosis and impaired quality of life when left&#xD;
      untreated. Advances in medical therapy have improved survival according to recent registries,&#xD;
      but are associated with high healthcare costs. Most treatment trials and clinical follow-up&#xD;
      assessments rely on the 6 minute walk distance as main outcome parameter although submaximal&#xD;
      exercise performance reflects only one disease aspect.&#xD;
&#xD;
      Reliable patient centered and prognostically relevant outcome measures are highly warranted&#xD;
      in the field of PH. With this prospective cohort study the investigator intend to gain&#xD;
      important information on the course of the disease and knowledge on the value of different&#xD;
      new and already established outcome parameters. New outcomes to be assessed will be home&#xD;
      based activity monitoring, novel physiological measures, namely cerebral and muscle tissue&#xD;
      oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand&#xD;
      test and several serum markers and micro-RNA. All these assessments will be compared with&#xD;
      hard endpoints events (death, lung-transplantation, hospitalization for PH), and with&#xD;
      traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic&#xD;
      quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility)&#xD;
      and cognitive function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Transplant free survival will be registered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the 6 minute walk distance</measure>
    <time_frame>10 years</time_frame>
    <description>The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New York Heart association (NYHA) functional class</measure>
    <time_frame>10 years</time_frame>
    <description>The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score in health related Quality of Life (HRQoL) questionnaires</measure>
    <time_frame>10 years</time_frame>
    <description>The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters by echocardiography</measure>
    <time_frame>10 years</time_frame>
    <description>The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital days</measure>
    <time_frame>10 years</time_frame>
    <description>Days spent in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>red- and white blood cell counts</measure>
    <time_frame>10 years</time_frame>
    <description>The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes</measure>
    <time_frame>10 years</time_frame>
    <description>The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test</measure>
    <time_frame>10 years</time_frame>
    <description>The change in utility will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overnight sleep study parameters</measure>
    <time_frame>10 years</time_frame>
    <description>The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score in cognitive function tests</measure>
    <time_frame>10 years</time_frame>
    <description>The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiopulmonary exercise test parameters</measure>
    <time_frame>10 years</time_frame>
    <description>The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG parameters</measure>
    <time_frame>10 years</time_frame>
    <description>The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motion, step counts, metabolic equivalent</measure>
    <time_frame>10 years</time_frame>
    <description>The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue</measure>
    <time_frame>10 years</time_frame>
    <description>Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time, maximal power in stair-ascent test</measure>
    <time_frame>10 years</time_frame>
    <description>Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance in Sit to stand test</measure>
    <time_frame>10 years</time_frame>
    <description>Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of C-reactive protein (CRP)</measure>
    <time_frame>10 years</time_frame>
    <description>The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of N-terminal brain natriuretic peptide (BNP)</measure>
    <time_frame>10 years</time_frame>
    <description>The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Hypertension Outcome Assessment</condition>
  <arm_group>
    <arm_group_label>PH target therapy</arm_group_label>
    <description>Patients receiving PH target therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PH target therapy according to physician</intervention_name>
    <description>Patients receiving PH target therapy</description>
    <arm_group_label>PH target therapy</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood will be collected for serum markers and micro-RNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with precapillary pulmonary hypertension classified according to WHO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with precapillary pulmonary hypertension&#xD;
&#xD;
          -  Adult male and female patients of all ages referred to our center for&#xD;
             evaluation/treatment of PH&#xD;
&#xD;
          -  Written informed consent by the subject after information about the research project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe concomitant left heart disease (left ventricular ejection&#xD;
             fraction &lt;40%).&#xD;
&#xD;
          -  Patients with restrictive lung disease (FVC&lt;60% predicted); obstructive lung disease&#xD;
             (forced expiratory volume (FEV) &lt;60% predicted, with FEV 1/FVC&lt;70%).&#xD;
&#xD;
          -  Patients with any other disease limiting their ability to move (skeletal disease,&#xD;
             neurological disease, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Ulrich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Department of Pulmonology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvia Ulrich, MD</last_name>
    <phone>++41442552220</phone>
    <email>pulmonalehypertonie@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabel Schmied</last_name>
    <phone>++41442552220</phone>
    <email>pulmonalehypertonie@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Zürich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Ulrich, PD MD</last_name>
      <phone>0041 44 255 22 20</phone>
      <email>silvia.ulrich@usz.ch</email>
    </contact>
    <investigator>
      <last_name>Silvia Ulrich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Hypertension</keyword>
  <keyword>Chronic thromboembolic pulmonary hypertension</keyword>
  <keyword>Pulmonary arterial hypertension</keyword>
  <keyword>Outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT02249806
org study id: 2014-0214_ZH PH Cohort
nct id: NCT02249806
lead sponsor: 
has dmc: No
PH is a serious disease with a dismal prognosis and impaired quality of life when left
      untreated. Reliable patient centered and prognostically relevant outcome measures are highly
      warranted in the field of PH. With this prospective cohort study the investigators intend to
      gain important information on the course of the disease and knowledge on the value of
      different new and already established outcome parameters.
PH is a serious disease with a dismal prognosis and impaired quality of life when left
      untreated. Advances in medical therapy have improved survival according to recent registries,
      but are associated with high healthcare costs. Most treatment trials and clinical follow-up
      assessments rely on the 6 minute walk distance as main outcome parameter although submaximal
      exercise performance reflects only one disease aspect.

      Reliable patient centered and prognostically relevant outcome measures are highly warranted
      in the field of PH. With this prospective cohort study the investigator intend to gain
      important information on the course of the disease and knowledge on the value of different
      new and already established outcome parameters. New outcomes to be assessed will be home
      based activity monitoring, novel physiological measures, namely cerebral and muscle tissue
      oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand
      test and several serum markers and micro-RNA. All these assessments will be compared with
      hard endpoints events (death, lung-transplantation, hospitalization for PH), and with
      traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic
      quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility)
      and cognitive function.
observational model: Cohort
time perspective: Prospective
measure: Survival
time frame: 10 years
description: Transplant free survival will be registered
measure: Change in the 6 minute walk distance
time frame: 10 years
description: The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
measure: New York Heart association (NYHA) functional class
time frame: 10 years
description: The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
measure: Score in health related Quality of Life (HRQoL) questionnaires
time frame: 10 years
description: The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
measure: Hemodynamic parameters by echocardiography
time frame: 10 years
description: The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
measure: Hospital days
time frame: 10 years
description: Days spent in the hospital
measure: red- and white blood cell counts
time frame: 10 years
description: The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
measure: Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
time frame: 10 years
description: The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)
measure: Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
time frame: 10 years
description: The change in utility will be registered at 3, 6, 12 months and yearly thereafter
measure: Overnight sleep study parameters
time frame: 10 years
description: The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
measure: Score in cognitive function tests
time frame: 10 years
description: The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
measure: Cardiopulmonary exercise test parameters
time frame: 10 years
description: The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
measure: ECG parameters
time frame: 10 years
description: The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
measure: Motion, step counts, metabolic equivalent
time frame: 10 years
description: The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
measure: Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
time frame: 10 years
description: Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
measure: Time, maximal power in stair-ascent test
time frame: 10 years
description: Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
measure: Performance in Sit to stand test
time frame: 10 years
description: Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
measure: Level of C-reactive protein (CRP)
time frame: 10 years
description: The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)
measure: Level of N-terminal brain natriuretic peptide (BNP)
time frame: 10 years
description: The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)
arm group label: PH target therapy
description: Patients receiving PH target therapy
intervention type: Other
intervention name: PH target therapy according to physician
description: Patients receiving PH target therapy
arm group label: PH target therapy
Venous blood will be collected for serum markers and micro-RNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Silvia Ulrich, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Department of Pulmonology
last name: Silvia Ulrich, MD
phone: ++41442552220
email: pulmonalehypertonie@usz.ch
last name: Isabel Schmied
phone: ++41442552220
email: pulmonalehypertonie@usz.ch
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension