<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/NCT01714752</url>
  </required_header>
  <id_info>
    <org_study_id>2012-02</org_study_id>
    <nct_id>NCT01714752</nct_id>
  </id_info>
  <brief_title>Evaluation of Left Ventricular Filling Pressures During Exercise</brief_title>
  <acronym>PREFFORT</acronym>
  <official_title>Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Cardiology Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Federation of Cardiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>French Cardiology Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health&#xD;
      issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been&#xD;
      shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures&#xD;
      elevated only at exercise (normal at rest).&#xD;
&#xD;
      Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as&#xD;
      a &quot;memory&quot; of chronic elevation of filling pressures. We believe that it is possible to&#xD;
      improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure&#xD;
      (LVEDP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose Heart failure with preserved ejection fraction (HFPEF) is common and is a real public&#xD;
      health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has&#xD;
      been shown that many patients with suspected HFPEF had left ventricular (LV) filling&#xD;
      pressures elevated only at exercise (normal at rest).&#xD;
&#xD;
      Hypothesis Using stress echocardiography and taking into account left atrial (LA) remodeling&#xD;
      at rest as a &quot;memory&quot; of chronic elevation of filling pressures. We believe that it is&#xD;
      possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic&#xD;
      pressure (LVEDP).&#xD;
&#xD;
      Methods Prospective, monocentric and comparative study: catheterization versus&#xD;
      echocardiography.&#xD;
&#xD;
      60 patients referred for coronary angiography will be recruited consecutively during their&#xD;
      hospitalization.&#xD;
&#xD;
      Patients should perform a low intensity and short duration exercise, in both catheterization&#xD;
      and echo labs (pedaling 3 minutes at 25Watts then, 3 minutes at 50W) The LVEDP will be&#xD;
      measured invasively with a pigtail, at rest and at both levels of exercise.&#xD;
&#xD;
      Echocardiography will be performed within 24 hours after catheterization, after a full&#xD;
      examination at rest, an identical exercise (same intensity, same duration, same position of&#xD;
      the patient) than made in catheterization lab will be done. Following parameters will be&#xD;
      recorded at both stress levels: trans mitral flow, mitral annular pulsed tissue Doppler&#xD;
      imaging (both lateral and septal) and tricuspid regurgitation flow.&#xD;
&#xD;
      The doctor who will perform the echocardiographic acquisitions will not be informed of the&#xD;
      results of catheterization. The acquisitions will be analyzed in a second time still blinded&#xD;
      to the catheterization data.&#xD;
&#xD;
      The following echocardiographic parameters will be collected and compared to the invasive&#xD;
      measurement of LVEDP:&#xD;
&#xD;
        -  Ratio between pulsed Doppler peak E velocity and peak Ea velocity obtained with tissue&#xD;
           Doppler imaging (E/Ea ratio) at rest and exercise,&#xD;
&#xD;
        -  maximal LA volume indexed to body area&#xD;
&#xD;
        -  (maximal LA volume) to (maximal LV volume) ratio.&#xD;
&#xD;
        -  LA distensibility defined by: (maximal LA volume - minimal LA volume) / (minimal LA&#xD;
           volume)&#xD;
&#xD;
        -  LA Global longitudinal strain Finally, it will be investigated whether the combined use&#xD;
           of E/Ea ratio at exercise with LA remodeling indices (of morphology and/or function)&#xD;
           improves the performance characteristics of diagnostic test, compared to a separate use&#xD;
           of these parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>E/Ea ratio</measure>
    <time_frame>Day 1</time_frame>
    <description>E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>left atrial (LA) morphology</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate left atrial (LA) morphology at rest (maximal LA volume indexed to body area, maximal LA volume to maximal LV volume ratio) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LA function at rest</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate LA function at rest (distensibility, global longitudinal strain) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>E/Ea ratio at exercise with LA remodeling indices at rest</measure>
    <time_frame>Day 1</time_frame>
    <description>To investigate whether the combined use of E/Ea ratio at exercise with LA remodeling indices at rest (of morphology and/or function) improves the performance characteristics of diagnostic test compared to a separate use of these parameters.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Heart Failure With Preserved Ejection Fraction (HFPEF)</condition>
  <condition>Left Ventricular End Diastolic Pressure (LVEDP)</condition>
  <arm_group>
    <arm_group_label>exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients perform exercise and pression measure is performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>measure of left ventricular and diastolic pressure at exercise</intervention_name>
    <arm_group_label>exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized for coronary angiography&#xD;
&#xD;
          -  Sinus Rhythm&#xD;
&#xD;
          -  Left ventricular Ejection Fraction &gt; 50%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18years&#xD;
&#xD;
          -  Hypertrophic Cardiomyopathy&#xD;
&#xD;
          -  Cardiac transplantation&#xD;
&#xD;
          -  Mitral stenosis&#xD;
&#xD;
          -  Mitral insufficiency &gt;2/4&#xD;
&#xD;
          -  Severe calcification of mitral annulus&#xD;
&#xD;
          -  Mitral prothesis or mitral repair&#xD;
&#xD;
          -  aortic prothesis&#xD;
&#xD;
          -  Severe aortic stenosis&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Acute coronary syndrom &lt; 3 months&#xD;
&#xD;
          -  Left ventricular thrombus&#xD;
&#xD;
          -  Severe renal Failure&#xD;
&#xD;
          -  failure of radial way for coronary angiography&#xD;
&#xD;
          -  coronary lesion indicating an angioplasty&#xD;
&#xD;
          -  impossibility to perform an exercise&#xD;
&#xD;
          -  refusal or inability to sign informed consent&#xD;
&#xD;
          -  no French medical insurance&#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_official>
    <last_name>Nadjib Hammoudi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiology department - Pitié Salpêtrière Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pitié Salpêtrière Hospital - Cardiology Department</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>September 27, 2013</last_update_submitted>
  <last_update_submitted_qc>September 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diagnosis</keyword>
  <keyword>Left ventricular end diastolic pressure (LVEDP)</keyword>
  <keyword>Exercise echocardiography</keyword>
  <keyword>Left atrial remodeling</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/NCT01714752
org study id: 2012-02
nct id: NCT01714752
lead sponsor: 
collaborator: 
has dmc: No
Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health
      issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been
      shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures
      elevated only at exercise (normal at rest).

      Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as
      a "memory" of chronic elevation of filling pressures. We believe that it is possible to
      improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure
      (LVEDP).
Purpose Heart failure with preserved ejection fraction (HFPEF) is common and is a real public
      health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has
      been shown that many patients with suspected HFPEF had left ventricular (LV) filling
      pressures elevated only at exercise (normal at rest).

      Hypothesis Using stress echocardiography and taking into account left atrial (LA) remodeling
      at rest as a "memory" of chronic elevation of filling pressures. We believe that it is
      possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic
      pressure (LVEDP).

      Methods Prospective, monocentric and comparative study: catheterization versus
      echocardiography.

      60 patients referred for coronary angiography will be recruited consecutively during their
      hospitalization.

      Patients should perform a low intensity and short duration exercise, in both catheterization
      and echo labs (pedaling 3 minutes at 25Watts then, 3 minutes at 50W) The LVEDP will be
      measured invasively with a pigtail, at rest and at both levels of exercise.

      Echocardiography will be performed within 24 hours after catheterization, after a full
      examination at rest, an identical exercise (same intensity, same duration, same position of
      the patient) than made in catheterization lab will be done. Following parameters will be
      recorded at both stress levels: trans mitral flow, mitral annular pulsed tissue Doppler
      imaging (both lateral and septal) and tricuspid regurgitation flow.

      The doctor who will perform the echocardiographic acquisitions will not be informed of the
      results of catheterization. The acquisitions will be analyzed in a second time still blinded
      to the catheterization data.

      The following echocardiographic parameters will be collected and compared to the invasive
      measurement of LVEDP:

        -  Ratio between pulsed Doppler peak E velocity and peak Ea velocity obtained with tissue
           Doppler imaging (E/Ea ratio) at rest and exercise,

        -  maximal LA volume indexed to body area

        -  (maximal LA volume) to (maximal LV volume) ratio.

        -  LA distensibility defined by: (maximal LA volume - minimal LA volume) / (minimal LA
           volume)

        -  LA Global longitudinal strain Finally, it will be investigated whether the combined use
           of E/Ea ratio at exercise with LA remodeling indices (of morphology and/or function)
           improves the performance characteristics of diagnostic test, compared to a separate use
           of these parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: E/Ea ratio
time frame: Day 1
description: E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise
measure: left atrial (LA) morphology
time frame: Day 1
description: To evaluate left atrial (LA) morphology at rest (maximal LA volume indexed to body area, maximal LA volume to maximal LV volume ratio) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.
measure: LA function at rest
time frame: Day 1
description: To evaluate LA function at rest (distensibility, global longitudinal strain) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.
measure: E/Ea ratio at exercise with LA remodeling indices at rest
time frame: Day 1
description: To investigate whether the combined use of E/Ea ratio at exercise with LA remodeling indices at rest (of morphology and/or function) improves the performance characteristics of diagnostic test compared to a separate use of these parameters.
arm group label: exercise
arm group type: Experimental
description: Patients perform exercise and pression measure is performed
intervention type: Procedure
intervention name: measure of left ventricular and diastolic pressure at exercise
arm group label: exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadjib Hammoudi, MD
role: Principal Investigator
affiliation: Cardiology department - Pitié Salpêtrière Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure