<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/NCT03810443</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180352</org_study_id>
    <nct_id>NCT03810443</nct_id>
  </id_info>
  <brief_title>Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension</brief_title>
  <acronym>HYPER2</acronym>
  <official_title>Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Dyspnea is a major symptom in pulmonary arterial hypertension and people with the same&#xD;
      haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension.&#xD;
      The hyperventilation syndrome is a frequent cause of dyspnea in general population and in&#xD;
      respiratory diseases like asthma but has never been studied in pulmonary hypertension. The&#xD;
      goal of this study is to measure the prevalence of pulmonary hypertension in a population of&#xD;
      patients with controlled pulmonary arterial hypertension (PAH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperventilation syndrome has been described as a cause of dyspnea in the general population&#xD;
      and in several chronic respiratory diseases such as asthma with 20 to 40% of asthmatics&#xD;
      affected. However, Hyperventilation syndrome has never been sought in a population with PAH.&#xD;
      Hyperventilation syndrome, although complex pathophysiology, may be simply corrected by a&#xD;
      management of respiratory physiotherapy based on the control of respiration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 14, 2019</start_date>
  <completion_date type="Anticipated">July 14, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 14, 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of the hyperventilation syndrome</measure>
    <time_frame>18 months</time_frame>
    <description>Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anxiety-depression questionary score</measure>
    <time_frame>18 months</time_frame>
    <description>results of anxiety-depression questionary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dyspnea score</measure>
    <time_frame>18 months</time_frame>
    <description>results of dyspnea questionary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life score</measure>
    <time_frame>18 months</time_frame>
    <description>results of quality of life questionary</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>pulmonary arterial hypertension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hyperventilation test</intervention_name>
    <description>The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.</description>
    <arm_group_label>pulmonary arterial hypertension</arm_group_label>
    <other_name>Questionnaire of Nijmegen</other_name>
    <other_name>Questionnaire of Dyspnea</other_name>
    <other_name>Questionnaire of quality of life</other_name>
    <other_name>Questionnaire of screening for psychological disorders</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. -&#xD;
             Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary&#xD;
             hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4&#xD;
             months.&#xD;
&#xD;
          -  Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP&#xD;
             &lt; 300ng/L or Brain Natriuretic Peptide(BNP) &lt; 50 ng/L and optimal hemodynamic results&#xD;
             measured by a right heart catheterization in the last year: right atrial pressure &lt; 8&#xD;
             mmHg, cardiac index &gt; 2,5 L/min/m2, veinous saturation in oxygen &gt; 65%)&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  Non-affiliation to a social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existence of another form of pulmonary hypertension&#xD;
&#xD;
          -  Existence of vocal cord dysfunction&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Obesity&gt; stage 2 (BMI 35 kg / m2)&#xD;
&#xD;
          -  Age ≥ 75 years&#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>Etienne-Marie JUTANT, CCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Etienne-Marie JUTANT, CCA</last_name>
    <phone>01 45 21 78 91</phone>
    <email>etiennemarie.jutant@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Bicêtre - Pneumology department</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Etienne-Marie JUTANT, CCA</last_name>
      <phone>01 45 21 78 91</phone>
      <email>etiennemarie.jutant@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hyperventilation</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03810443
org study id: APHP180352
nct id: NCT03810443
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dyspnea is a major symptom in pulmonary arterial hypertension and people with the same
      haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension.
      The hyperventilation syndrome is a frequent cause of dyspnea in general population and in
      respiratory diseases like asthma but has never been studied in pulmonary hypertension. The
      goal of this study is to measure the prevalence of pulmonary hypertension in a population of
      patients with controlled pulmonary arterial hypertension (PAH).
Hyperventilation syndrome has been described as a cause of dyspnea in the general population
      and in several chronic respiratory diseases such as asthma with 20 to 40% of asthmatics
      affected. However, Hyperventilation syndrome has never been sought in a population with PAH.
      Hyperventilation syndrome, although complex pathophysiology, may be simply corrected by a
      management of respiratory physiotherapy based on the control of respiration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prevalence of the hyperventilation syndrome
time frame: 18 months
description: Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension
measure: anxiety-depression questionary score
time frame: 18 months
description: results of anxiety-depression questionary
measure: dyspnea score
time frame: 18 months
description: results of dyspnea questionary
measure: quality of life score
time frame: 18 months
description: results of quality of life questionary
arm group label: pulmonary arterial hypertension
arm group type: Experimental
description: The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.
intervention type: Diagnostic Test
intervention name: Hyperventilation test
description: The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.
arm group label: pulmonary arterial hypertension
other name: Questionnaire of Nijmegen
other name: Questionnaire of Dyspnea
other name: Questionnaire of quality of life
other name: Questionnaire of screening for psychological disorders
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Etienne-Marie JUTANT, CCA
role: Principal Investigator
affiliation: APHP
last name: Etienne-Marie JUTANT, CCA
phone: 01 45 21 78 91
email: etiennemarie.jutant@aphp.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hyperventilation
mesh term: Hypertension
sharing ipd: No