<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/NCT02223559</url>
  </required_header>
  <id_info>
    <org_study_id>25-593 ex 12/13</org_study_id>
    <nct_id>NCT02223559</nct_id>
  </id_info>
  <brief_title>Non-invasive Assessment of Pulmonary Artery Pressure</brief_title>
  <official_title>Non-invasive Assessment of Pulmonary Artery Pressure and Right Ventricular Function in Patients With Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Bank of Austria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ludwig Boltzmann Institute for Lung Vascular Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular&#xD;
      function stand in the focus of the diagnosis and clinical management of pulmonary&#xD;
      hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure&#xD;
      PAP and to provide hemodynamic information on right ventricular function. However, due to its&#xD;
      invasive nature, RHC is not optimal for screening and for close monitoring of the disease.&#xD;
      Therefore, the development of non-invasive methods providing reliable PAP measurements and&#xD;
      right ventricular functional parameters would be of major benefit.&#xD;
&#xD;
      Today, the most often used comprehensive non-invasive method for these purposes is&#xD;
      echocardiography. However, the method has limitations; in many cases PAP is significantly&#xD;
      under- or overestimated - especially in subjects with co-existing pulmonary diseases.&#xD;
      Regarding right ventricular function, although novel echocardiography parameters appear to be&#xD;
      promising, they have not yet been evaluated in all forms of PH.&#xD;
&#xD;
      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is&#xD;
      considered to be as gold standard for the non-invasive assessment of right ventricular&#xD;
      function. In addition, our group showed that with a special approach (&quot;vortex method&quot;), MRI&#xD;
      enables the determination of PAP with physiologic accuracy, but the method has not yet been&#xD;
      validated systematically in different forms of PH.&#xD;
&#xD;
      All patients undergoing right heart catheterization in our clinic are candidates for the&#xD;
      study. Excluded will be patients not eligible for MRI or declining to take part in the study.&#xD;
      MRI and Echocardiography will be performed within two weeks of the RHC.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad&#xD;
           collective of patients with PH of diverse ethology.&#xD;
&#xD;
        2. MRI derived right ventricular functional parameters correlate better to invasive&#xD;
           measurements and to established prognostic parameters than echocardiography derived&#xD;
           right ventricular functional parameters.&#xD;
&#xD;
        3. Novel right ventricular tissue Doppler parameters add substantially to &quot;classical&quot;&#xD;
           echocardiography parameters to describe right ventricular function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>mean pulmonary artery pressure</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>right ventricular function parameters</measure>
    <time_frame>at baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>right heart catheterization patients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma samples will be retrained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing right heart catheterization due to clinical reasons&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: patients undergoing right heart catheterization due to clinical reasons&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: patients not eligible for MRI, patients not agreeing with investigation&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Horst Olschewski, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</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>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/NCT02223559
org study id: 25-593 ex 12/13
nct id: NCT02223559
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular
      function stand in the focus of the diagnosis and clinical management of pulmonary
      hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure
      PAP and to provide hemodynamic information on right ventricular function. However, due to its
      invasive nature, RHC is not optimal for screening and for close monitoring of the disease.
      Therefore, the development of non-invasive methods providing reliable PAP measurements and
      right ventricular functional parameters would be of major benefit.

      Today, the most often used comprehensive non-invasive method for these purposes is
      echocardiography. However, the method has limitations; in many cases PAP is significantly
      under- or overestimated - especially in subjects with co-existing pulmonary diseases.
      Regarding right ventricular function, although novel echocardiography parameters appear to be
      promising, they have not yet been evaluated in all forms of PH.

      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is
      considered to be as gold standard for the non-invasive assessment of right ventricular
      function. In addition, our group showed that with a special approach ("vortex method"), MRI
      enables the determination of PAP with physiologic accuracy, but the method has not yet been
      validated systematically in different forms of PH.

      All patients undergoing right heart catheterization in our clinic are candidates for the
      study. Excluded will be patients not eligible for MRI or declining to take part in the study.
      MRI and Echocardiography will be performed within two weeks of the RHC.

      Hypothesis:

        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad
           collective of patients with PH of diverse ethology.

        2. MRI derived right ventricular functional parameters correlate better to invasive
           measurements and to established prognostic parameters than echocardiography derived
           right ventricular functional parameters.

        3. Novel right ventricular tissue Doppler parameters add substantially to "classical"
           echocardiography parameters to describe right ventricular function.
observational model: Cohort
time perspective: Prospective
measure: mean pulmonary artery pressure
time frame: at baseline
measure: right ventricular function parameters
time frame: at baseline
arm group label: right heart catheterization patients
Serum and plasma samples will be retrained
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Horst Olschewski, Prof.
role: Principal Investigator
affiliation: Medical University of Graz
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension