<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/NCT03231774</url>
  </required_header>
  <id_info>
    <org_study_id>HDZ-KA_011_HF</org_study_id>
    <nct_id>NCT03231774</nct_id>
  </id_info>
  <brief_title>Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization</brief_title>
  <official_title>Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart and Diabetes Center North-Rhine Westfalia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart and Diabetes Center North-Rhine Westfalia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart&#xD;
      Catheterization in Terms of accuracy to measure hemodynamic parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic heart failure is a progressive disease in Western population. Echocardiography and&#xD;
      right heart catheterization are important tools in the diagnosis and progress monitoring of&#xD;
      heart failure.&#xD;
&#xD;
      Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right&#xD;
      heart catheterization. However, this diagnostic device represents an invasive method that is&#xD;
      additionally associated with high risks such as infections, vessel and nerve injuries.&#xD;
      Echocardiography is probably in a position to determine hemodynamic parameters as reliably as&#xD;
      right heart catheterization without additional health risk due to its non-invasive character.&#xD;
      All procedures performed are part of clinical Routine. Patients do not undergo any&#xD;
      study-specific procedure at all.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Measurement of systolic, diastolic and mean CVP</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>CVP measured in mmHg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of systolic, diastolic and mean PAP</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>PAP measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of systolic, diastolic and mean RVP</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>RVP measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of systolic, diastolic and mean PAWP</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>PAWP measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Cardiac Index CI</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>CI measured in l/M/m²</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Cardiac Output CO</measure>
    <time_frame>During a single right heart catheterization procedure</time_frame>
    <description>CO measured in l/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transthoracic Echocardiography</measure>
    <time_frame>During a single TTE examination</time_frame>
    <description>Collected data will be analyzed for comparability</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients scheduled for transthoracic echocardiography and right heart catheterization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic heart failure NYHA I - IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>NRW</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.</citation>
    <PMID>25242802</PMID>
  </results_reference>
  <results_reference>
    <citation>Szymczyk T, Sauzet O, Paluszkiewicz LJ, Costard-Jackle A, Potratz M, Rudolph V, Gummert JF, Fox H. Non-invasive assessment of central venous pressure in heart failure: a systematic prospective comparison of echocardiography and Swan-Ganz catheter. Int J Cardiovasc Imaging. 2020 Oct;36(10):1821-1829. doi: 10.1007/s10554-020-01889-3. Epub 2020 May 22.</citation>
    <PMID>32445006</PMID>
  </results_reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Echocardiography</keyword>
  <keyword>Right heart catheterization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03231774
org study id: HDZ-KA_011_HF
nct id: NCT03231774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart
      Catheterization in Terms of accuracy to measure hemodynamic parameters.
Chronic heart failure is a progressive disease in Western population. Echocardiography and
      right heart catheterization are important tools in the diagnosis and progress monitoring of
      heart failure.

      Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right
      heart catheterization. However, this diagnostic device represents an invasive method that is
      additionally associated with high risks such as infections, vessel and nerve injuries.
      Echocardiography is probably in a position to determine hemodynamic parameters as reliably as
      right heart catheterization without additional health risk due to its non-invasive character.
      All procedures performed are part of clinical Routine. Patients do not undergo any
      study-specific procedure at all.
observational model: Cohort
time perspective: Prospective
measure: Measurement of systolic, diastolic and mean CVP
time frame: During a single right heart catheterization procedure
description: CVP measured in mmHg
measure: Measurement of systolic, diastolic and mean PAP
time frame: During a single right heart catheterization procedure
description: PAP measured in mmHg
measure: Measurement of systolic, diastolic and mean RVP
time frame: During a single right heart catheterization procedure
description: RVP measured in mmHg
measure: Measurement of systolic, diastolic and mean PAWP
time frame: During a single right heart catheterization procedure
description: PAWP measured in mmHg
measure: Measurement of Cardiac Index CI
time frame: During a single right heart catheterization procedure
description: CI measured in l/M/m²
measure: Measurement of Cardiac Output CO
time frame: During a single right heart catheterization procedure
description: CO measured in l/min
measure: Transthoracic Echocardiography
time frame: During a single TTE examination
description: Collected data will be analyzed for comparability
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
citation: Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.
PMID: 25242802
citation: Szymczyk T, Sauzet O, Paluszkiewicz LJ, Costard-Jackle A, Potratz M, Rudolph V, Gummert JF, Fox H. Non-invasive assessment of central venous pressure in heart failure: a systematic prospective comparison of echocardiography and Swan-Ganz catheter. Int J Cardiovasc Imaging. 2020 Oct;36(10):1821-1829. doi: 10.1007/s10554-020-01889-3. Epub 2020 May 22.
PMID: 32445006
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No