<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/NCT02980887</url>
  </required_header>
  <id_info>
    <org_study_id>16-860</org_study_id>
    <nct_id>NCT02980887</nct_id>
  </id_info>
  <brief_title>Pulmonary Vascular Disease Phenomics Program PVDOMICS</brief_title>
  <acronym>PVDOMICS</acronym>
  <official_title>Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is recognized that patients with various forms of heart and lung disease exhibit varying&#xD;
      degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular&#xD;
      dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not&#xD;
      well understood. Rapid advances in high throughput omic methodology, combined with powerful&#xD;
      bioinformatics and network biology capability, have created the opportunity to conduct&#xD;
      studies that broadly search for homologies and differences across the spectrum of disease&#xD;
      states associated with pulmonary hypertension, and determinants of the spectrum of right&#xD;
      ventricular compensation that accompanies these conditions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol is designed to lead to new understanding of patients with pulmonary hypertension&#xD;
      and right heart dysfunction, based on molecular, clinical, hemodynamic and radiographic&#xD;
      characteristics. New classifications will be a product of association of these in depth&#xD;
      phenotypic descriptions with specific molecular mechanisms of pathogenesis. The protocol will&#xD;
      be implemented to lead to identification of both sub-phenotypes of lung vascular disease and&#xD;
      to biomarkers of disease that may be useful for early diagnosis or for assessment of&#xD;
      interventions to prevent or treat this condition.&#xD;
&#xD;
      A longitudinal study in a subset of the participants enrolled in the parent cross-sectional&#xD;
      study will:&#xD;
&#xD;
        1. Retest participants at a minimum 6 month interval from initial evaluation to collect a&#xD;
           core set of clinical and OMICS features. This will include survival, clinical staging,&#xD;
           clinical group assignment, 6-minute walk, echocardiography, and blood for a broad&#xD;
           collection of selected OMICS tests, to include proteomics and other variables found to&#xD;
           be informative in the initial set.&#xD;
&#xD;
        2. Associate and compare OMICS data with clinical sets and OMICS clusters between baseline&#xD;
           and follow-up interval, with attention to reproducibility, predictive capacity as&#xD;
           biomarkers for diagnosis, disease progression, phenotypic changes, functional capacity,&#xD;
           therapeutic response and survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2029</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Precision based definitions of pulmonary vascular diseases (PVD)</measure>
    <time_frame>Over 5 years</time_frame>
    <description>OMICs analyses will be used to assign new class of PVD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of biomarkers for PVD</measure>
    <time_frame>5 years</time_frame>
    <description>OMICs and other measures of disease</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1195</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy controls No intervention as this is an observational study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary Vascular Disease</arm_group_label>
    <description>Pulmonary Vascular Disease at risk for pulmonary hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary Hypertension</arm_group_label>
    <description>Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>There is no intervention in this observational study</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Pulmonary Hypertension</arm_group_label>
    <arm_group_label>Pulmonary Vascular Disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples for Omics analyses, including DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pulmonary hypertension, Pulmonary hypertension vascular, and healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cross-sectional (parent) study:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Patients ages &gt;18 years of age referred for right heart catheterization for further&#xD;
        evaluation of known PVD or to be at risk for PVD due to established cardiac disease or&#xD;
        pulmonary disease&#xD;
&#xD;
          -  Able to perform complete diagnostic testing listed subsequently (cardiac&#xD;
             catheterization, echo, exercise test, PFT's, ECG, chest CT, quality of life&#xD;
             questionnaires, ventilation/perfusion scan, cardiac MRI, body composition&#xD;
             bioimpedance, and sleep study)&#xD;
&#xD;
          -  Subject signs informed consent to perform required testing for the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Dialysis dependent renal function; In the clinician's opinion, too ill to perform the&#xD;
        protocol testing; Pregnant or nursing&#xD;
&#xD;
        Longitudinal study:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Any PH, comparators or control participant previously enrolled in the parent PVDOMICS&#xD;
             protocol with a minimum of six months post-enrollment&#xD;
&#xD;
          -  Dialysis dependent renal function since the parent study acceptable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participant Level 1 (clinic visit):&#xD;
&#xD;
          -  Transplant other than heart or lung&#xD;
&#xD;
          -  In the clinician's opinion, too ill to perform L-PVDOMICS testing even if limited&#xD;
             testing.&#xD;
&#xD;
          -  Participants who withdrew from the parent PVDOMICS study&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Concurrent participation in any investigational drug study or other clinical trial&#xD;
&#xD;
        Participant Level 2 (telephone visit):&#xD;
&#xD;
          -  Transplant other than heart or lung&#xD;
&#xD;
          -  Participants who withdrew from the parent PVDOMICS study&#xD;
&#xD;
        Participant Level 3 (medical chart review):&#xD;
&#xD;
        - Participants who withdrew from the parent PVDOMICS study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas S Hill, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tufts University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lei Xiao, MD</last_name>
    <role>Study Director</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona Health Sciences Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary arterial hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Plan for sharing with outside network investigators is being developed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Being decided</ipd_time_frame>
    <ipd_access_criteria>Being decided</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT02980887
org study id: 16-860
nct id: NCT02980887
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
It is recognized that patients with various forms of heart and lung disease exhibit varying
      degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular
      dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not
      well understood. Rapid advances in high throughput omic methodology, combined with powerful
      bioinformatics and network biology capability, have created the opportunity to conduct
      studies that broadly search for homologies and differences across the spectrum of disease
      states associated with pulmonary hypertension, and determinants of the spectrum of right
      ventricular compensation that accompanies these conditions
The protocol is designed to lead to new understanding of patients with pulmonary hypertension
      and right heart dysfunction, based on molecular, clinical, hemodynamic and radiographic
      characteristics. New classifications will be a product of association of these in depth
      phenotypic descriptions with specific molecular mechanisms of pathogenesis. The protocol will
      be implemented to lead to identification of both sub-phenotypes of lung vascular disease and
      to biomarkers of disease that may be useful for early diagnosis or for assessment of
      interventions to prevent or treat this condition.

      A longitudinal study in a subset of the participants enrolled in the parent cross-sectional
      study will:

        1. Retest participants at a minimum 6 month interval from initial evaluation to collect a
           core set of clinical and OMICS features. This will include survival, clinical staging,
           clinical group assignment, 6-minute walk, echocardiography, and blood for a broad
           collection of selected OMICS tests, to include proteomics and other variables found to
           be informative in the initial set.

        2. Associate and compare OMICS data with clinical sets and OMICS clusters between baseline
           and follow-up interval, with attention to reproducibility, predictive capacity as
           biomarkers for diagnosis, disease progression, phenotypic changes, functional capacity,
           therapeutic response and survival.
observational model: Cohort
time perspective: Prospective
measure: Precision based definitions of pulmonary vascular diseases (PVD)
time frame: Over 5 years
description: OMICs analyses will be used to assign new class of PVD
measure: Identification of biomarkers for PVD
time frame: 5 years
description: OMICs and other measures of disease
arm group label: Controls
description: Healthy controls No intervention as this is an observational study
arm group label: Pulmonary Vascular Disease
description: Pulmonary Vascular Disease at risk for pulmonary hypertension
arm group label: Pulmonary Hypertension
description: Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension
intervention type: Other
intervention name: No Intervention
description: There is no intervention in this observational study
arm group label: Controls
arm group label: Pulmonary Hypertension
arm group label: Pulmonary Vascular Disease
Samples for Omics analyses, including DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicholas S Hill, MD
role: Study Chair
affiliation: Tufts University Medical Center
last name: Lei Xiao, MD
role: Study Director
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension
mesh term: Vascular Diseases
sharing ipd: Yes
ipd description: Plan for sharing with outside network investigators is being developed.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Being decided
ipd access criteria: Being decided