<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/NCT01729702</url>
  </required_header>
  <id_info>
    <org_study_id>2008-08</org_study_id>
    <nct_id>NCT01729702</nct_id>
  </id_info>
  <brief_title>Neurohormonal Parameters in Hypertrophic Cardiomyopathies</brief_title>
  <acronym>REEF-CMH</acronym>
  <official_title>Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Cardiology Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Cardiology Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to demonstrate that changes in plasma levels of&#xD;
      circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise&#xD;
      correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise&#xD;
      ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and&#xD;
      their relationships with extent of MRI myocardial fibrosis with the degree of exercise&#xD;
      functional limitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine</measure>
    <time_frame>Day 1 at rest and during exercise</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy</condition>
  <condition>2- Obstructive Hypertrophic Cardiomyopathy</condition>
  <condition>3- Non Obstructive Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>single group - consecutive patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample collection</intervention_name>
    <arm_group_label>single group - consecutive patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Age 18 to 75 years&#xD;
&#xD;
          -  Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with&#xD;
             studies of exercise peak oxygen consumption and cardiac MRI with gadolinium&#xD;
             late-enhancement&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Patient with a social insurance Patient at rest&#xD;
&#xD;
          -  - Age 18 to 75 years&#xD;
&#xD;
          -  Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Patient with a social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Insufficient echogenicity&#xD;
&#xD;
          -  Permanent atrial fibrillation&#xD;
&#xD;
          -  Complete BBB on the ECG&#xD;
&#xD;
          -  LVEF &lt; 35 %&#xD;
&#xD;
          -  Previous septal ablation (surgical or percutaneous)&#xD;
&#xD;
          -  Simultaneous participation to another biomedical research&#xD;
&#xD;
        If exercise needed:&#xD;
&#xD;
          -  contraindication to exercise : hemodynamic instability, uncontrolled high blood&#xD;
             pressure (&gt;220/120 mmHg), severe aortic stenosis&#xD;
&#xD;
          -  Inability to exercise (muscular, pulmonary, elderly patient)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert Hagège, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>HEGP - Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>March 25, 2014</last_update_submitted>
  <last_update_submitted_qc>March 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>1- Hypertrophic cardiomyopathy</keyword>
  <keyword>2- BNP</keyword>
  <keyword>3- NT-proBNP</keyword>
  <keyword>4- Neurohormons</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT01729702
org study id: 2008-08
nct id: NCT01729702
lead sponsor: 
has dmc: No
The primary purpose of this study is to demonstrate that changes in plasma levels of
      circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise
      correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise
      ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)
The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and
      their relationships with extent of MRI myocardial fibrosis with the degree of exercise
      functional limitation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
time frame: Day 1 at rest and during exercise
arm group label: single group - consecutive patients
arm group type: Other
intervention type: Other
intervention name: blood sample collection
arm group label: single group - consecutive patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Albert Hagège, MD-PhD
role: Study Chair
affiliation: HEGP - Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy