<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/NCT02977546</url>
  </required_header>
  <id_info>
    <org_study_id>HDZNRW-KA_008_TB</org_study_id>
    <nct_id>NCT02977546</nct_id>
  </id_info>
  <brief_title>Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure</brief_title>
  <official_title>Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determination of hemodynamics plays an important role in the diagnosis of chronic heart&#xD;
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter&#xD;
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to&#xD;
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.&#xD;
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine&#xD;
      hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery&#xD;
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies&#xD;
      investigated the accuracy, precision and trending abilities of noninvasive pulse contour&#xD;
      analysis during anesthesia and in the intensive care unit, but there is no data available for&#xD;
      its use in patients with chronic heart failure. The investigators therefore initiated this&#xD;
      Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with&#xD;
      chronic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Determination of hemodynamics plays an important role in the diagnosis of chronic heart&#xD;
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter&#xD;
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to&#xD;
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.&#xD;
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine&#xD;
      hemodynamics noninvasively via a finger cuff. Advantages towards pulmonary artery&#xD;
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies&#xD;
      investigated the accuracy, precision and trend abilities of noninvasive pulse contour&#xD;
      analysis during anesthesia and in the intensive care unit, but there is no data for its use&#xD;
      in patients with chronic heart failure. The investigators therefore initiated this Trial to&#xD;
      verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart&#xD;
      failure. For NPCA the investigators use the CNAP monitor (CNSystems Medizintechnik AG). As a&#xD;
      reference method the investigators use intermittent thermodilution via PAC (TD). Three&#xD;
      averaged autocalibrated NPCA-CO-measurements are going to be validated against three averaged&#xD;
      TD-CO-measurements. Moreover, measurements of cardiac index, stroke volume, systemic vascular&#xD;
      resistance and a between-calibration-drift will be performed. The investigators will assess&#xD;
      the accuracy and precision of the individual values.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Cardiac Output (l/min)</measure>
    <time_frame>1 day</time_frame>
    <description>Three repeated and averaged measurements in a row of both methods within a range of &lt;= 10%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac index (l/min/m2)</measure>
    <time_frame>1 day</time_frame>
    <description>Three repeated and averaged measurements in a row of both methods within a range of &lt;= 10%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume (ml)</measure>
    <time_frame>1 day</time_frame>
    <description>Three repeated and averaged measurements in a row of both methods within a range of &lt;= 10%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic vascular resistance (dyn*sec/cm5)</measure>
    <time_frame>1 day</time_frame>
    <description>Three repeated and averaged measurements in a row of both methods within a range of &lt;= 10%</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Between-Calibration-Drift</measure>
    <time_frame>1 day</time_frame>
    <description>One measurement before and after a new calibration including finger change</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <description>Patients with chronic heart failure NYHA &gt;= 2 based on a reduced left ventricular ejection fraction (LV-EF &lt;= 45%). All patients receive pulmonary artery catheterization and noninvasive pulse contour Analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive pulse contour analysis</intervention_name>
    <description>For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)</description>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulmonary artery catheterization</intervention_name>
    <description>As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay</description>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic heart failure NYHA &gt;= 2 based on a reduced left ventricular ejection&#xD;
        fraction (LV-EF &lt;= 45%).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic heart failure NYHA &gt;= 2 based on a reduced left ventricular ejection fraction&#xD;
             (LV-EF &lt;= 45%)&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high-grade tricuspid insufficiency&#xD;
&#xD;
          -  implantation of a ventricular assist device (VAD)&#xD;
&#xD;
          -  NIBP difference &gt;= 20 mmHg between left and right arm before investigation&#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>Thomas Bitter, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart and Diabetes Center NRW</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic for Cardiology, Herz- und Diabetszentrum NRW, Ruhr-Universität Bochum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>March 14, 2017</last_update_submitted>
  <last_update_submitted_qc>March 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heart and Diabetes Center North-Rhine Westfalia</investigator_affiliation>
    <investigator_full_name>Thomas Bitter</investigator_full_name>
    <investigator_title>Principal Investigator, Consultant for Cardiology and Pneumology, Doctor of medicine</investigator_title>
  </responsible_party>
  <keyword>Hemodynamics</keyword>
  <keyword>Noninvasive</keyword>
  <keyword>Pulse contour analysis</keyword>
  <keyword>Heart failure</keyword>
  <keyword>Swan Ganz Catheterization</keyword>
  <keyword>Pulmonary artery Catheter</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/NCT02977546
org study id: HDZNRW-KA_008_TB
nct id: NCT02977546
lead sponsor: 
has dmc: No
Determination of hemodynamics plays an important role in the diagnosis of chronic heart
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine
      hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies
      investigated the accuracy, precision and trending abilities of noninvasive pulse contour
      analysis during anesthesia and in the intensive care unit, but there is no data available for
      its use in patients with chronic heart failure. The investigators therefore initiated this
      Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with
      chronic heart failure.
Determination of hemodynamics plays an important role in the diagnosis of chronic heart
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine
      hemodynamics noninvasively via a finger cuff. Advantages towards pulmonary artery
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies
      investigated the accuracy, precision and trend abilities of noninvasive pulse contour
      analysis during anesthesia and in the intensive care unit, but there is no data for its use
      in patients with chronic heart failure. The investigators therefore initiated this Trial to
      verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart
      failure. For NPCA the investigators use the CNAP monitor (CNSystems Medizintechnik AG). As a
      reference method the investigators use intermittent thermodilution via PAC (TD). Three
      averaged autocalibrated NPCA-CO-measurements are going to be validated against three averaged
      TD-CO-measurements. Moreover, measurements of cardiac index, stroke volume, systemic vascular
      resistance and a between-calibration-drift will be performed. The investigators will assess
      the accuracy and precision of the individual values.
observational model: Cohort
time perspective: Prospective
measure: Cardiac Output (l/min)
time frame: 1 day
description: Three repeated and averaged measurements in a row of both methods within a range of <= 10%
measure: Cardiac index (l/min/m2)
time frame: 1 day
description: Three repeated and averaged measurements in a row of both methods within a range of <= 10%
measure: Stroke volume (ml)
time frame: 1 day
description: Three repeated and averaged measurements in a row of both methods within a range of <= 10%
measure: Systemic vascular resistance (dyn*sec/cm5)
time frame: 1 day
description: Three repeated and averaged measurements in a row of both methods within a range of <= 10%
measure: Between-Calibration-Drift
time frame: 1 day
description: One measurement before and after a new calibration including finger change
arm group label: Heart Failure
description: Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%). All patients receive pulmonary artery catheterization and noninvasive pulse contour Analysis.
intervention type: Device
intervention name: Noninvasive pulse contour analysis
description: For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)
arm group label: Heart Failure
intervention type: Device
intervention name: Pulmonary artery catheterization
description: As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay
arm group label: Heart Failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Thomas Bitter, Dr. med.
role: Principal Investigator
affiliation: Heart and Diabetes Center NRW
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heart and Diabetes Center North-Rhine Westfalia
investigator full name: Thomas Bitter
investigator title: Principal Investigator, Consultant for Cardiology and Pneumology, Doctor of medicine
mesh term: Heart Failure
sharing ipd: No