<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/NCT02207868</url>
  </required_header>
  <id_info>
    <org_study_id>EVA 3D</org_study_id>
    <nct_id>NCT02207868</nct_id>
  </id_info>
  <brief_title>3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH</brief_title>
  <acronym>EVA3D</acronym>
  <official_title>3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)</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 document the left and right ventricular function in patients with&#xD;
      sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results&#xD;
      of this study should help to generate hypothesis for further future studies.&#xD;
&#xD;
      The primary hypothesis is that the increased use of modern image guided methods could provide&#xD;
      essential aspects for the follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 3D echocardiography could provide early and detailed information about the changes in the&#xD;
      left and right ventricle.&#xD;
&#xD;
      The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather&#xD;
      adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal&#xD;
      strain soon to adapt the PAH specific therapy accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 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>Change of the left ventricular longitudinal strain</measure>
    <time_frame>day 90 (+/- 7 days)</time_frame>
    <description>echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wall thickness</measure>
    <time_frame>90 days (+/- 7 days)</time_frame>
    <description>echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular ejection fracture</measure>
    <time_frame>90 days (+/- 7 Days)</time_frame>
    <description>echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular stroke volume</measure>
    <time_frame>90 days (+/- 7 days)</time_frame>
    <description>echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tricuspid Annular Plane Systolic Excursion (TAPSE)</measure>
    <time_frame>90 days (+/- 7 days)</time_frame>
    <description>echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>right ventricular fractional area change</measure>
    <time_frame>90 (+/- 7 days)</time_frame>
    <description>echocardiography</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>no treatment</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with pulmonary arterial hypertension associated with WHO group 1 who start with a&#xD;
        parenteral prostanoidtherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;17&#xD;
&#xD;
          -  pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a&#xD;
             parenteral prostanoid-therapy&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  prostanoid naive&#xD;
&#xD;
          -  no change of the PAH specific therapy within 3 weeks of the recruitment to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and lactation period&#xD;
&#xD;
          -  Women of child bearing 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 malignant&#xD;
             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 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial 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/NCT02207868
org study id: EVA 3D
nct id: NCT02207868
lead sponsor: 
has dmc: No
The aim of the study is to document the left and right ventricular function in patients with
      sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results
      of this study should help to generate hypothesis for further future studies.

      The primary hypothesis is that the increased use of modern image guided methods could provide
      essential aspects for the follow up.
The 3D echocardiography could provide early and detailed information about the changes in the
      left and right ventricle.

      The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather
      adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal
      strain soon to adapt the PAH specific therapy accordingly.
observational model: Cohort
time perspective: Prospective
measure: Change of the left ventricular longitudinal strain
time frame: day 90 (+/- 7 days)
description: echocardiography
measure: wall thickness
time frame: 90 days (+/- 7 days)
description: echocardiography
measure: left ventricular ejection fracture
time frame: 90 days (+/- 7 Days)
description: echocardiography
measure: left ventricular stroke volume
time frame: 90 days (+/- 7 days)
description: echocardiography
measure: Tricuspid Annular Plane Systolic Excursion (TAPSE)
time frame: 90 days (+/- 7 days)
description: echocardiography
measure: right ventricular fractional area change
time frame: 90 (+/- 7 days)
description: echocardiography
arm group label: no treatment
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
sharing ipd: Undecided