<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/NCT04467242</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0372</org_study_id>
    <nct_id>NCT04467242</nct_id>
  </id_info>
  <brief_title>Right Ventricular Diastolic Dysfunction</brief_title>
  <acronym>RVDD</acronym>
  <official_title>Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are&#xD;
      very commonly associated.&#xD;
&#xD;
      Emphysema by increasing intrathoracic pressure appears to affect cardiac function.&#xD;
&#xD;
      Interestingly, previous studies have shown a link between the telediastolic volume of the&#xD;
      right ventricle (measured by RMI) and the intensity of emphysema.&#xD;
&#xD;
      Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or&#xD;
      accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.&#xD;
&#xD;
      To verify this hypothesis the investigators will perform KT loop procedures in order to&#xD;
      acquire intracardiac pressure/volume curves before and after lung volume reduction.&#xD;
&#xD;
      The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac&#xD;
      contractility and loading conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the change in right diastolic cardiac function after reduction of emphysema</measure>
    <time_frame>1 day</time_frame>
    <description>Estimate the change in right diastolic cardiac function after reduction of emphysema : assessed by the change in the slope end diastolic pressure volume relationship (EDPVR mmHg/ml) obtained by KT Loop procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate the change in right systolic heart function</measure>
    <time_frame>1 day</time_frame>
    <description>Estimate the change in right systolic heart function before and after reduction of emphysema assessed by the cardiac output (L/min), the stroke volume (ml), the end systolic pressure (mmHg), the end systolic volume (mmHg), obtained by KT Loop procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the change in right cardiac contractility</measure>
    <time_frame>1 day</time_frame>
    <description>Estimate the change in right cardiac contractility before and after reduction of emphysema assessed by the slope end systolic pressure volume relationship (mmHg/ml), obtained by KT Loop procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate ventriculo-arterial coupling</measure>
    <time_frame>1 day</time_frame>
    <description>Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the evolution of symptoms assessed</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing exercice performance</measure>
    <time_frame>1 day</time_frame>
    <description>Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the evolution of respiratory function</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate the evolution of respiratory function before and after reduction of emphysema assessed by the FEV1 (Liters and % of predicted value), the FVC (Liters and % of predicted value), the RV (Liters and % of predicted value), the TLC (Liters and % of predicted value) obtained by spirometry/plethysmography.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COPD</condition>
  <condition>Emphysema</condition>
  <condition>Right Heart Dysfunction</condition>
  <arm_group>
    <arm_group_label>COPD patients</arm_group_label>
    <description>COPD patients with severe emphysema and right heart dysfunction</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients with severe emphysema and right heart dysfunction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  At least 40 years&#xD;
&#xD;
          -  A smoking history&#xD;
&#xD;
          -  Smoking cessation ≥ 6 months&#xD;
&#xD;
          -  FEV1/FVC ≤ 0,7&#xD;
&#xD;
          -  Severe emphysema (destruction ≥ 50%)&#xD;
&#xD;
          -  Peak tricuspid regurgitation velocity &lt; 2,8 m/s or presence of other echocardiographic&#xD;
             &quot;PH signs&quot;&#xD;
&#xD;
          -  15% ≤ FEV1post ≤ 50%&#xD;
&#xD;
          -  Residual volume ≥ 175% predicted&#xD;
&#xD;
          -  TLC ≥ 100% predicted&#xD;
&#xD;
          -  Optimal medical management&#xD;
&#xD;
          -  150m ≤ 6MWD ≤ 500m&#xD;
&#xD;
          -  mMRC ≥ 2&#xD;
&#xD;
          -  Physical activity ≥ 2/Week (≥ 30minutes)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  ≥2 hospitalizations/year for EACOPD&#xD;
&#xD;
          -  Recent EACOPD (≤ 3months)&#xD;
&#xD;
          -  ≥ 50ml mucus/day&#xD;
&#xD;
          -  PAPm ≥35mmHg&#xD;
&#xD;
          -  PaCO2 ≥ 55mmHg&#xD;
&#xD;
          -  Bubble ≥ 1/3 hemithorax&#xD;
&#xD;
          -  Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery&#xD;
&#xD;
          -  Left ventricular ejection fraction ≤ 45%, unstable heart disease&#xD;
&#xD;
          -  Life expectancy ≤ 1 year&#xD;
&#xD;
          -  Contraindication to anesthesia&#xD;
&#xD;
          -  Allergy to nitinol or silicone&#xD;
&#xD;
          -  Corticotherapy ≥ 10mg/day&#xD;
&#xD;
          -  Patient under legal protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaud Bourdin, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arnaud Bourdin, MD PhD</last_name>
    <phone>467336091</phone>
    <phone_ext>33</phone_ext>
    <email>a-bourdin@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Uh Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud BOURDIN, MD PhD</last_name>
      <phone>46733609</phone>
      <phone_ext>33</phone_ext>
      <email>a-bourdin@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 27, 2020</last_update_submitted>
  <last_update_submitted_qc>November 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</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>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04467242
org study id: RECHMPL20_0372
nct id: NCT04467242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are
      very commonly associated.

      Emphysema by increasing intrathoracic pressure appears to affect cardiac function.

      Interestingly, previous studies have shown a link between the telediastolic volume of the
      right ventricle (measured by RMI) and the intensity of emphysema.

      Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or
      accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.

      To verify this hypothesis the investigators will perform KT loop procedures in order to
      acquire intracardiac pressure/volume curves before and after lung volume reduction.

      The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac
      contractility and loading conditions.
observational model: Case-Only
time perspective: Retrospective
measure: Estimate the change in right diastolic cardiac function after reduction of emphysema
time frame: 1 day
description: Estimate the change in right diastolic cardiac function after reduction of emphysema : assessed by the change in the slope end diastolic pressure volume relationship (EDPVR mmHg/ml) obtained by KT Loop procedure
measure: Estimate the change in right systolic heart function
time frame: 1 day
description: Estimate the change in right systolic heart function before and after reduction of emphysema assessed by the cardiac output (L/min), the stroke volume (ml), the end systolic pressure (mmHg), the end systolic volume (mmHg), obtained by KT Loop procedure
measure: Estimate the change in right cardiac contractility
time frame: 1 day
description: Estimate the change in right cardiac contractility before and after reduction of emphysema assessed by the slope end systolic pressure volume relationship (mmHg/ml), obtained by KT Loop procedure.
measure: Estimate ventriculo-arterial coupling
time frame: 1 day
description: Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure
measure: Evaluate the evolution of symptoms assessed
time frame: 1 day
description: Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.
measure: Assessing exercice performance
time frame: 1 day
description: Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.
measure: Evaluate the evolution of respiratory function
time frame: 1 day
description: Evaluate the evolution of respiratory function before and after reduction of emphysema assessed by the FEV1 (Liters and % of predicted value), the FVC (Liters and % of predicted value), the RV (Liters and % of predicted value), the TLC (Liters and % of predicted value) obtained by spirometry/plethysmography.
arm group label: COPD patients
description: COPD patients with severe emphysema and right heart dysfunction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud Bourdin, MD PhD
role: Study Director
affiliation: University Hospital, Montpellier
last name: Arnaud Bourdin, MD PhD
phone: 467336091
phone ext: 33
email: a-bourdin@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Emphysema
mesh term: Emphysema
sharing ipd: Undecided
ipd description: NC