<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/NCT03770390</url>
  </required_header>
  <id_info>
    <org_study_id>7650</org_study_id>
    <nct_id>NCT03770390</nct_id>
  </id_info>
  <brief_title>Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations</brief_title>
  <acronym>HeartSoar</acronym>
  <official_title>Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations</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 main objective of this study is to characterize the cardiorespiratory functional gain in&#xD;
      patients with pectus excavatum following corrective surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary objectives are:&#xD;
&#xD;
        -  To measure the quality of life of patients operated on for pectus excavatum&#xD;
&#xD;
        -  Identify and describe post-operative complications&#xD;
&#xD;
        -  Follow-up on the body mass index changes post-surgery&#xD;
&#xD;
        -  Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is&#xD;
           placed non-invasively&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 16, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>This single group study documents changes before and after surgical correction of pectus excavatum.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in: Oxygen pulse (mL O2 / heart beat)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>Recorded during incremental exercise testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in: Body mass index (kg/m^2)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: The presence/absence of dyspnea during exercise</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: The presence/absence of palpitations</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: The presence/absence of psychosocial impact</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: VO2MAX (ml/kg/min)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>Maximum oxygen consumption during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: VO2MAX (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>Maximum oxygen consumption during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Maximum heart rate (bpm)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>Maximum heart rate during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Presence/absence of an anomaly in oxygen pulse</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Ventilatory threshold (% of VO2MAX)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>The ventilatory threshold during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Breathing Reserve (% of maximum voluntary ventilation)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
    <description>The breathing reserved during incremental exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Forced expiratory volume in 1 second (liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Forced expiratory volume in 1 second (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Forced vital capacity (liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Forced vital capacity (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Residual volume (liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Residual volume (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Total lung capacity (liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Total lung capacity (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Residual volume / Total lung capacity (liters/liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Functional residual capacity (liters)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in: Functional residual capacity (% predicted)</measure>
    <time_frame>post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The SF36 questionnaire</measure>
    <time_frame>post-op (expected maximum of 4 years)</time_frame>
    <description>This is a general health related quality of life questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Body Esteem Scale</measure>
    <time_frame>post-op (expected maximum of 4 years)</time_frame>
    <description>This questionnaire treats body esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Rosenberg Self Esteem Scale</measure>
    <time_frame>post-op (expected maximum of 4 years)</time_frame>
    <description>This questionnaire treats self esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>per-op up to expected maximum of 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (average, mmHg)</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (SpO2, %)</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac index (liters/min/m^2)</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in ejection volume (%)</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indexed systolic ejection volume (ml/beat/m2)</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative dose of vasopressors</measure>
    <time_frame>during surgery (day 0)</time_frame>
    <description>Per-operative hemodynamic measures</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Funnel Chest</condition>
  <arm_group>
    <arm_group_label>The study population</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period.&#xD;
Intervention: Surgical correction of pectus excavatum</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical correction of pectus excavatum</intervention_name>
    <description>Surgical correction of pectus excavatum</description>
    <arm_group_label>The study population</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with pectus excavatum&#xD;
&#xD;
          -  The patient received corrective surgery within four years of enrollment and is&#xD;
             scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery&#xD;
             during the inclusion period&#xD;
&#xD;
          -  Collection of informed written consent (patient and legal guardian, if applicable)&#xD;
&#xD;
          -  Obligation of affiliation or beneficiary of a social security programme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility for the patient to participate in his/her next annual follow-up visit&#xD;
&#xD;
          -  Absence of exercise test data AND respiratory function test data performed during the&#xD;
             preoperative check-up&#xD;
&#xD;
          -  Subject in exclusion period required by another protocol&#xD;
&#xD;
          -  Pregnant or lactating woman, patient unable to give consent, protected adult,&#xD;
             vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7,&#xD;
             L.1211-8, L.1211-9)&#xD;
&#xD;
          -  Subject deprived of liberty by judicial or administrative decision&#xD;
&#xD;
          -  Participation of the subject in another interventional protocol&#xD;
&#xD;
          -  Failure to properly inform the patient (e.g. a language barrier)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurence Solovei, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals of Montpellier, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurence Solovei, MD</last_name>
    <phone>+33.(0)4.67.33.62.70</phone>
    <email>l-solovei@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Arnaud de Villeneuve - CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laurence Solovei, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arnaud Bourdin, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</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>Funnel Chest</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/NCT03770390
org study id: 7650
nct id: NCT03770390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to characterize the cardiorespiratory functional gain in
      patients with pectus excavatum following corrective surgery.
The secondary objectives are:

        -  To measure the quality of life of patients operated on for pectus excavatum

        -  Identify and describe post-operative complications

        -  Follow-up on the body mass index changes post-surgery

        -  Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is
           placed non-invasively
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This single group study documents changes before and after surgical correction of pectus excavatum.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in: Oxygen pulse (mL O2 / heart beat)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: Recorded during incremental exercise testing.
measure: Change in: Body mass index (kg/m^2)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of dyspnea during exercise
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of palpitations
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of psychosocial impact
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: VO2MAX (ml/kg/min)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: Maximum oxygen consumption during incremental exercise testing.
measure: Change in: VO2MAX (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: Maximum oxygen consumption during incremental exercise testing.
measure: Change in: Maximum heart rate (bpm)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: Maximum heart rate during incremental exercise testing.
measure: Change in: Presence/absence of an anomaly in oxygen pulse
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.
measure: Change in: Ventilatory threshold (% of VO2MAX)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: The ventilatory threshold during incremental exercise testing.
measure: Change in: Breathing Reserve (% of maximum voluntary ventilation)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
description: The breathing reserved during incremental exercise testing.
measure: Change in: Forced expiratory volume in 1 second (liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced expiratory volume in 1 second (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced vital capacity (liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced vital capacity (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume (liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Total lung capacity (liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Total lung capacity (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume / Total lung capacity (liters/liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Functional residual capacity (liters)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Functional residual capacity (% predicted)
time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: The SF36 questionnaire
time frame: post-op (expected maximum of 4 years)
description: This is a general health related quality of life questionnaire.
measure: The Body Esteem Scale
time frame: post-op (expected maximum of 4 years)
description: This questionnaire treats body esteem.
measure: The Rosenberg Self Esteem Scale
time frame: post-op (expected maximum of 4 years)
description: This questionnaire treats self esteem.
measure: Complications
time frame: per-op up to expected maximum of 4 years
measure: Blood pressure (average, mmHg)
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Pulse
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Oxygen saturation (SpO2, %)
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Cardiac index (liters/min/m^2)
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Variation in ejection volume (%)
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Indexed systolic ejection volume (ml/beat/m2)
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
measure: Cumulative dose of vasopressors
time frame: during surgery (day 0)
description: Per-operative hemodynamic measures
arm group label: The study population
arm group type: Other
description: Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period.
Intervention: Surgical correction of pectus excavatum
intervention type: Procedure
intervention name: Surgical correction of pectus excavatum
description: Surgical correction of pectus excavatum
arm group label: The study population
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Laurence Solovei, MD
role: Principal Investigator
affiliation: University Hospitals of Montpellier, France
last name: Laurence Solovei, MD
phone: +33.(0)4.67.33.62.70
email: l-solovei@chu-montpellier.fr
facility: 
status: Recruiting
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Funnel Chest
sharing ipd: Undecided