<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/NCT04471129</url>
  </required_header>
  <id_info>
    <org_study_id>2019/0400/HP</org_study_id>
    <nct_id>NCT04471129</nct_id>
  </id_info>
  <brief_title>Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study</brief_title>
  <acronym>HiFlow-Heart</acronym>
  <official_title>Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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 investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy&#xD;
      could have a beneficial impact in patients with heart failure, particularly by lowering&#xD;
      capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation&#xD;
      are difficult to predict due to the lack of data in the literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to carry out a prospective randomized cross-over prospective&#xD;
      physiological study comparing, Non-Invasive Ventilation and High Flow Oxygen Therapy in&#xD;
      patients with chronic uncompensated heart failure. This stable population would make it&#xD;
      possible to easily study variations in a physiological parameter without any added risk for&#xD;
      the patient, but with all the pathophysiological parameters transposable to the situation of&#xD;
      decompensated heart failure.&#xD;
&#xD;
      Indeed, it is accepted that the existence of heart failure with decreased left ventricular&#xD;
      ejection fraction (LVEF) (&lt; 40%) exposes patients to a high risk of congestive cardiac&#xD;
      decompensation due to the associated presence of diastolic dysfunction1.&#xD;
&#xD;
      The study will be conducted using an alternating design, where a patient receives the two&#xD;
      treatments one after the other (&quot;cross-over&quot;), because the alternating design, compared to&#xD;
      the two parallel arm design, reduces the number of patients needed to show a given difference&#xD;
      between High Flow Oxygen Therapy and Non-Invasive Ventilation at equal power, if there is&#xD;
      neither an order-of-prescription effect (&quot;period&quot;) nor a residual effect of the first&#xD;
      treatment on the second treatment (&quot;carry-over&quot;). In order to avoid a residual effect on&#xD;
      changes in pressure or oxygenation, a wash-out period on conventional oxygen therapy (O2C)&#xD;
      should be set between the two treatments (High Flow Oxygen Therapy and Non-Invasive&#xD;
      Ventilation) administered to the same patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">October 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>sequential assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No applicable</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures</measure>
    <time_frame>Day 1</time_frame>
    <description>Difference between High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures as assessed by the occluded pulmonary artery occlusion pressure (in mmHg) measured by Swan-Ganz pulmonary artery catheterization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function</measure>
    <time_frame>Day 1</time_frame>
    <description>Arterial pressure [mmHg] measured by Swan-Ganz catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation</measure>
    <time_frame>Day 1</time_frame>
    <description>Arterial oxygen saturation, SaO2 [%], measured by Swan-Ganz catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume</measure>
    <time_frame>Day 1</time_frame>
    <description>End-expiratory lung impedance (mean of 3 measures), measured by PulmoVista (Draeger, Germany)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient comfort</measure>
    <time_frame>Day 1</time_frame>
    <description>Patient's evaluation of comfort on Visual Analog Scale (10 points)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HFO/O2C/NIV</intervention_name>
    <description>High-flow oxygen therapy + O2C + Non invasive ventilation</description>
    <arm_group_label>High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NIV/O2C/HFO</intervention_name>
    <description>Non invasive ventilation + O2C + High-flow oxygen therapy</description>
    <arm_group_label>Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Major patient&#xD;
&#xD;
          2. Patient who has undergone cardiac surgery with extracorporeal circulation for more&#xD;
             than 24 hours and has been extubated for at least 6 hours.&#xD;
&#xD;
          3. Pre-operative heart failure with left ventricular ejection fraction &lt; 40%.&#xD;
&#xD;
          4. Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) with transpulmonary&#xD;
             thermodilution and by radial arterial catheter intended for use in the intra- and&#xD;
             post-operative monitoring of the patient.&#xD;
&#xD;
          5. Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for&#xD;
             more than 30 minuts, without signs of hypoxemia (SpO292%)&#xD;
&#xD;
          6. Stable hemodynamic parameters: no changes in hemodynamic parameters (arterial&#xD;
             pressures and pulmonary and cardiac index) by more than 10% over the 30 minutes prior&#xD;
             to inclusion and no increase in cardiotropic medication for at least 30 minutes.&#xD;
&#xD;
          7. Patient with an oxygenation rate ≤ 6L&#xD;
&#xD;
          8. For women of child-bearing age: negative pregnancy test at inclusion&#xD;
&#xD;
          9. Person who has read and understood the information letter and signed the consent form&#xD;
&#xD;
         10. Affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to the use of NIV or HFO&#xD;
&#xD;
          2. Patient with orotracheal intubation or tracheotomy&#xD;
&#xD;
          3. Renal failure with hemodialysis or hemofiltration&#xD;
&#xD;
          4. Uncontrolled state of shock (PAS&lt;90 mmHg and/or cardiac index&lt;1.8 L/min/m² and/or&#xD;
             norepinephrine&gt;0.2 μg/kg/min and/or dobutamine&gt;10 μg/kg/min)&#xD;
&#xD;
          5. Acute respiratory failure as defined by :&#xD;
&#xD;
               -  clinical signs: respiratory rate &gt;35/min, signs of struggle, SpO2&lt;92% on O2C&#xD;
&#xD;
               -  indication for treatment with NIV or HFO at the discretion of the clinician&#xD;
&#xD;
               -  oxygen dependency requiring O2C&gt;6L/min O2C flow at the oxygen mask&#xD;
&#xD;
          6. Chronic advanced respiratory disease&#xD;
&#xD;
          7. Chronic treatment with NIV or CPAP at home&#xD;
&#xD;
          8. Non-operated aortic or mitral insufficiency ≥ II/IV&#xD;
&#xD;
          9. Administration of loop diuretics within 3 hours prior to inclusion for intravenous&#xD;
             forms and within 6 hours for oral forms.&#xD;
&#xD;
         10. Presence of altered consciousness defined by a Glasgow score &lt; 15/15 or cognitive&#xD;
             dysfunction defined by a CAM-ICU score &gt; 0/4&#xD;
&#xD;
         11. Pregnant or parturient or nursing woman or proven lack of effective contraception&#xD;
&#xD;
         12. Person deprived of liberty by an administrative or judicial decision or person placed&#xD;
             under judicial protection / subtutorship or guardianship&#xD;
&#xD;
         13. Person participating in another trial / having participated in another trial that may&#xD;
             interfere with the procedures that are the subject of the research within a 4-week&#xD;
             time frame&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elisabeth Surlemont, Dr</last_name>
    <phone>+33232881705</phone>
    <email>Elisabeth.Surlemont@chu-rouen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emmanuel Besnier, Dr</last_name>
    <phone>+332888283</phone>
    <email>Emmanuel.Besnier@chu-rouen.fr</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic heart failure</keyword>
  <keyword>heart surgery</keyword>
  <keyword>invasive mechanical ventilation</keyword>
  <keyword>high flow oxygen therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT04471129
org study id: 2019/0400/HP
nct id: NCT04471129
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy
      could have a beneficial impact in patients with heart failure, particularly by lowering
      capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation
      are difficult to predict due to the lack of data in the literature.
The investigators propose to carry out a prospective randomized cross-over prospective
      physiological study comparing, Non-Invasive Ventilation and High Flow Oxygen Therapy in
      patients with chronic uncompensated heart failure. This stable population would make it
      possible to easily study variations in a physiological parameter without any added risk for
      the patient, but with all the pathophysiological parameters transposable to the situation of
      decompensated heart failure.

      Indeed, it is accepted that the existence of heart failure with decreased left ventricular
      ejection fraction (LVEF) (< 40%) exposes patients to a high risk of congestive cardiac
      decompensation due to the associated presence of diastolic dysfunction1.

      The study will be conducted using an alternating design, where a patient receives the two
      treatments one after the other ("cross-over"), because the alternating design, compared to
      the two parallel arm design, reduces the number of patients needed to show a given difference
      between High Flow Oxygen Therapy and Non-Invasive Ventilation at equal power, if there is
      neither an order-of-prescription effect ("period") nor a residual effect of the first
      treatment on the second treatment ("carry-over"). In order to avoid a residual effect on
      changes in pressure or oxygenation, a wash-out period on conventional oxygen therapy (O2C)
      should be set between the two treatments (High Flow Oxygen Therapy and Non-Invasive
      Ventilation) administered to the same patient.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: sequential assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: No applicable
measure: High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures
time frame: Day 1
description: Difference between High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures as assessed by the occluded pulmonary artery occlusion pressure (in mmHg) measured by Swan-Ganz pulmonary artery catheterization
measure: Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function
time frame: Day 1
description: Arterial pressure [mmHg] measured by Swan-Ganz catheter
measure: Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation
time frame: Day 1
description: Arterial oxygen saturation, SaO2 [%], measured by Swan-Ganz catheter
measure: Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume
time frame: Day 1
description: End-expiratory lung impedance (mean of 3 measures), measured by PulmoVista (Draeger, Germany)
measure: Patient comfort
time frame: Day 1
description: Patient's evaluation of comfort on Visual Analog Scale (10 points)
arm group label: High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation
arm group type: Other
description: oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation
arm group label: Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy
arm group type: Other
description: oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy
intervention type: Other
intervention name: HFO/O2C/NIV
description: High-flow oxygen therapy + O2C + Non invasive ventilation
arm group label: High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation
intervention type: Other
intervention name: NIV/O2C/HFO
description: Non invasive ventilation + O2C + High-flow oxygen therapy
arm group label: Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elisabeth Surlemont, Dr
phone: +33232881705
email: Elisabeth.Surlemont@chu-rouen.fr
last name: Emmanuel Besnier, Dr
phone: +332888283
email: Emmanuel.Besnier@chu-rouen.fr
responsible party type: Sponsor
mesh term: Heart Failure