<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/NCT03030807</url>
  </required_header>
  <id_info>
    <org_study_id>28-037 ex 15/16</org_study_id>
    <nct_id>NCT03030807</nct_id>
  </id_info>
  <brief_title>Pulmonary Hypertension in Hypersensitivity Pneumonitis</brief_title>
  <official_title>Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ludwig Boltzmann Institute for Lung Vascular Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <brief_summary>
    <textblock>
      The investigation serves the identification of pulmonary hypertension (PH) among patients&#xD;
      with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data&#xD;
      from South America indicate that the prevalence of pre-capillary PH amongst patients with HP&#xD;
      is higher than 20%. There are no reliable data from Europe so far. According to the&#xD;
      investigators previous analysis, more than 400 HP patients have participated in pulmonary&#xD;
      rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg&#xD;
      (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is&#xD;
      to be invited to participate in the study.&#xD;
&#xD;
      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical&#xD;
      suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the&#xD;
      determination of the prevalence of PH in patients with HP the investigators aim to assess the&#xD;
      reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Prevalence of pulmonary hypertension</measure>
    <time_frame>4 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">426</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Right heart catheterization (in case of suspected PH)</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed Hypersensitivity Pneumonitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed Hypersensitivity Pneumonitis&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
          -  Age: 18-90 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe impairment of the general health condition&#xD;
&#xD;
          -  pregnancy&#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>Horst Olschewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Alveolitis, Extrinsic Allergic</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03030807
org study id: 28-037 ex 15/16
nct id: NCT03030807
lead sponsor: 
collaborator: 
The investigation serves the identification of pulmonary hypertension (PH) among patients
      with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data
      from South America indicate that the prevalence of pre-capillary PH amongst patients with HP
      is higher than 20%. There are no reliable data from Europe so far. According to the
      investigators previous analysis, more than 400 HP patients have participated in pulmonary
      rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg
      (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is
      to be invited to participate in the study.

      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical
      suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the
      determination of the prevalence of PH in patients with HP the investigators aim to assess the
      reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of pulmonary hypertension
time frame: 4 year
intervention type: Diagnostic Test
intervention name: Right heart catheterization (in case of suspected PH)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Horst Olschewski, MD
role: Principal Investigator
affiliation: Medical University of Graz
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Hypertension, Pulmonary
mesh term: Alveolitis, Extrinsic Allergic
mesh term: Hypertension
mesh term: Hypersensitivity