<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/NCT02198456</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol PARIS3D</org_study_id>
    <nct_id>NCT02198456</nct_id>
  </id_info>
  <brief_title>Imaging Control Study, 3D Echo, MR and RHC.</brief_title>
  <acronym>PARIS</acronym>
  <official_title>Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regina Steringer-Mascherbauer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elisabethinen Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to intensify the follow up of patients with pulmonary arterial&#xD;
      hypertension via modern imaging guided methods in due consideration of the possibilities of&#xD;
      three-dimensional echocardiography in order to optimize their specific therapy.&#xD;
&#xD;
      The hypothesis is that the increased use of modern imaging guided tools is essential for the&#xD;
      follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is not possible to perform a magnetic resonance imaging in all patients and as a result&#xD;
      echocardiography is not only done at screening but also during the follow up. The imaging&#xD;
      technologies made a great progress in the last few years and enable a better assessment of&#xD;
      the haemodynamic parameters in our days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>right ventricular ejection fracture</measure>
    <time_frame>month 12 (+/- 7 days)</time_frame>
    <description>right-sided heart catheterization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>right atrial pressure</measure>
    <time_frame>12 month (+/- 7 days)</time_frame>
    <description>right-sided heart catheterization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index (CI)/cardiac output (CO)</measure>
    <time_frame>12 months (+/- 7 Days)</time_frame>
    <description>right-sided heart catheterization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary vascular resistance</measure>
    <time_frame>12 months (+/- 7 days)</time_frame>
    <description>right-sided heart catheterization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean pulmonary capillary wedge pressure</measure>
    <time_frame>12 month (+/-7 days)</time_frame>
    <description>right-sided heart catheterization</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Pulmonary Arterial Hypertension WHO Group I</condition>
  <arm_group>
    <arm_group_label>3D echocardiography</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        pulmonary arterial hypertension WHO group I&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;17&#xD;
&#xD;
          -  pulmonary arterial hypertension WHO group I who are going to start a therapy with&#xD;
             prostanoid&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  Prostanoid naive&#xD;
&#xD;
          -  no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion&#xD;
             into the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and lactation period&#xD;
&#xD;
          -  Women of childbearing potential who do not use an effective and secure method for&#xD;
             birth control&#xD;
&#xD;
          -  severe chronic kidney insufficiency (glomerular filtration rate &lt;30), which will&#xD;
             remain for more than 3 months&#xD;
&#xD;
          -  liver insufficiency Child C&#xD;
&#xD;
          -  life expectancy shorter than the course of the study (for example because of a&#xD;
             malignant disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Regina Steringer-Mascherbauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Krankenhaus der Elisabethinen Linz GmbH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Regina Steringer-Mascherbauer, MD</last_name>
    <phone>0043/732/7676</phone>
    <phone_ext>4916</phone_ext>
    <email>regina.mascherbauer@elisabethinen.or.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Ploechl</last_name>
    <phone>0043/732/7676</phone>
    <phone_ext>4415</phone_ext>
    <email>andrea.ploechl@elisabethinen.or.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Krankenhaus der Elisabethinen Linz GmbH</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Regina Steringer-Mascherbauer, MD</last_name>
      <phone>0043/732/7676</phone>
      <phone_ext>4916</phone_ext>
      <email>regina.mascherbauer@elisabethinen.or.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Elisabethinen Hospital</investigator_affiliation>
    <investigator_full_name>Regina Steringer-Mascherbauer</investigator_full_name>
    <investigator_title>OA Dr.</investigator_title>
  </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>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02198456
org study id: Protocol PARIS3D
nct id: NCT02198456
lead sponsor: 
has dmc: No
The aim of the study is to intensify the follow up of patients with pulmonary arterial
      hypertension via modern imaging guided methods in due consideration of the possibilities of
      three-dimensional echocardiography in order to optimize their specific therapy.

      The hypothesis is that the increased use of modern imaging guided tools is essential for the
      follow up.
It is not possible to perform a magnetic resonance imaging in all patients and as a result
      echocardiography is not only done at screening but also during the follow up. The imaging
      technologies made a great progress in the last few years and enable a better assessment of
      the haemodynamic parameters in our days.
observational model: Cohort
time perspective: Prospective
measure: right ventricular ejection fracture
time frame: month 12 (+/- 7 days)
description: right-sided heart catheterization
measure: right atrial pressure
time frame: 12 month (+/- 7 days)
description: right-sided heart catheterization
measure: cardiac index (CI)/cardiac output (CO)
time frame: 12 months (+/- 7 Days)
description: right-sided heart catheterization
measure: pulmonary vascular resistance
time frame: 12 months (+/- 7 days)
description: right-sided heart catheterization
measure: mean pulmonary capillary wedge pressure
time frame: 12 month (+/-7 days)
description: right-sided heart catheterization
arm group label: 3D echocardiography
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Regina Steringer-Mascherbauer, MD
role: Principal Investigator
affiliation: Krankenhaus der Elisabethinen Linz GmbH
last name: Regina Steringer-Mascherbauer, MD
phone: 0043/732/7676
phone ext: 4916
email: regina.mascherbauer@elisabethinen.or.at
last name: Andrea Ploechl
phone: 0043/732/7676
phone ext: 4415
email: andrea.ploechl@elisabethinen.or.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Elisabethinen Hospital
investigator full name: Regina Steringer-Mascherbauer
investigator title: OA Dr.
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
sharing ipd: Undecided