<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/NCT03818373</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0400</org_study_id>
    <secondary_id>UF 7512</secondary_id>
    <nct_id>NCT03818373</nct_id>
  </id_info>
  <brief_title>Respiratory Drive in Patients With Univentricular Congenital Heart Disease</brief_title>
  <official_title>Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?</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>
      The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest&#xD;
      and the VE/VCO2 slope measured during cardiopulmonary exercise testing.&#xD;
&#xD;
      The hypothesis is that patient with univentricular congenital heart disease have a increasing&#xD;
      of respiratory drive like chronic heart failure. This increasing of respiratory drive could&#xD;
      participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise&#xD;
      testing and in the genese of central apnea index during the sleep.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with univentricular congenital heart disease will perform :&#xD;
&#xD;
        -  a cardiopulmonary exercise testing with measure VE/VCO2 slope,&#xD;
&#xD;
        -  a measure of the respiratory drive to hypercapnia with occlusion pressure during the&#xD;
           rebreathing with at rest (P0,1/PetCO2).&#xD;
&#xD;
        -  A polysomnography with a scoring of central apnea index. Correlation will be evaluate&#xD;
           between P 0,1/PetCO2 with VE/VCO2 slope and between P0,1/PetCO2 central apnea index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">July 7, 2021</completion_date>
  <primary_completion_date type="Actual">July 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>all participants receive the same intervention throughout the protocol</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest</measure>
    <time_frame>day 90 after inclusion visit (visit 2)</time_frame>
    <description>between the measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest&#xD;
- between VE/VCO2 slope during a cardiopulmonary exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pearson correlation</measure>
    <time_frame>day 90 after inclusion visit (visit 2)</time_frame>
    <description>between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and Central apnea index scored with a polysomnography during a night&#xD;
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and NYHA, New York Heart Association Functional Classification&#xD;
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and the quality of life evaluated by questionary&#xD;
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and data of cardiac echography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Univentricular Heart</condition>
  <condition>Children, Adult</condition>
  <arm_group>
    <arm_group_label>Patients with univentricular congenital heart disease</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients 8 years old or more with functionally univentricular congenital heart disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>polysomnography</intervention_name>
    <description>Sleep examination strictly non-invasive with skin sensors. This exploration would allow for the detection of respiratory sleep disorders and consider of appropriate management for patients.</description>
    <arm_group_label>Patients with univentricular congenital heart disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Functionally univentricular congenital heart disease&#xD;
&#xD;
          -  Age ≥ 8 years&#xD;
&#xD;
          -  Consent of the adult patient or the parents or legal guardians of the minor patient.&#xD;
&#xD;
          -  Beneficiary of the social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Size &lt;120 cm (minimum size for the stress test)&#xD;
&#xD;
          -  Medical contraindication to exercise test or presence of : myocardial infarction less&#xD;
             than 3 months old, unstable angina, uncontrolled severe arrhythmias, symptomatic&#xD;
             aortic stenosis, uncontrolled heart failure, pulmonary embolism, evolutionary&#xD;
             phlebitis, pericarditis, myocarditis, progressive endocarditis, aortic dissection&#xD;
&#xD;
          -  Unstable patient with severe intellectual disability or complex pathology making&#xD;
             polysomnography impossible&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan MOREAU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montpellier University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C</name>
      <address>
        <city>Montpellier</city>
        <state>Occitanie</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Saint-Pierre</name>
      <address>
        <city>Palavas-les-Flots</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Univentricular congenital heart</keyword>
  <keyword>Sleep apnea</keyword>
  <keyword>Polysomnography</keyword>
  <keyword>Respiratory drive</keyword>
  <keyword>VE/VCO2 slope</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Univentricular Heart</mesh_term>
  </condition_browse>
  <!-- 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/NCT03818373
org study id: RECHMPL17_0400
secondary id: UF 7512
nct id: NCT03818373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest
      and the VE/VCO2 slope measured during cardiopulmonary exercise testing.

      The hypothesis is that patient with univentricular congenital heart disease have a increasing
      of respiratory drive like chronic heart failure. This increasing of respiratory drive could
      participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise
      testing and in the genese of central apnea index during the sleep.
The patients with univentricular congenital heart disease will perform :

        -  a cardiopulmonary exercise testing with measure VE/VCO2 slope,

        -  a measure of the respiratory drive to hypercapnia with occlusion pressure during the
           rebreathing with at rest (P0,1/PetCO2).

        -  A polysomnography with a scoring of central apnea index. Correlation will be evaluate
           between P 0,1/PetCO2 with VE/VCO2 slope and between P0,1/PetCO2 central apnea index.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: all participants receive the same intervention throughout the protocol
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
time frame: day 90 after inclusion visit (visit 2)
description: between the measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
- between VE/VCO2 slope during a cardiopulmonary exercise
measure: Pearson correlation
time frame: day 90 after inclusion visit (visit 2)
description: between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and Central apnea index scored with a polysomnography during a night
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and NYHA, New York Heart Association Functional Classification
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and the quality of life evaluated by questionary
between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and data of cardiac echography
arm group label: Patients with univentricular congenital heart disease
arm group type: Other
description: Patients 8 years old or more with functionally univentricular congenital heart disease
intervention type: Procedure
intervention name: polysomnography
description: Sleep examination strictly non-invasive with skin sensors. This exploration would allow for the detection of respiratory sleep disorders and consider of appropriate management for patients.
arm group label: Patients with univentricular congenital heart disease
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Johan MOREAU
role: Principal Investigator
affiliation: Montpellier University Hospital
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Univentricular Heart