<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/NCT02260362</url>
  </required_header>
  <id_info>
    <org_study_id>14126</org_study_id>
    <nct_id>NCT02260362</nct_id>
  </id_info>
  <brief_title>Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease</brief_title>
  <acronym>ItinerAir</acronym>
  <official_title>Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease</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 complex congenital cardiac malformations are a significant number of different diseases,&#xD;
      each having specific natural histories. The interface with pulmonary arterial hypertension&#xD;
      (HTAP) is high since the physiology of many of these disorders comprises alterations in&#xD;
      pulmonary vasculature.&#xD;
&#xD;
      This observatory is a cohort of 400 patients enrolled in 3 years, older than one month,&#xD;
      having been informed and have agreed to participate in the study and with congenital heart&#xD;
      disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension&#xD;
      confirmed by cardiac catheterization.&#xD;
&#xD;
      The main objectives of this report are to know&#xD;
&#xD;
        -  Incidence of congenital heart disease in HTAP France.&#xD;
&#xD;
        -  Describe the natural history of HTAP in a large population of patients Congenital heart&#xD;
           disease in France&#xD;
&#xD;
        -  The characteristics of HTAP congenital heart disease&#xD;
&#xD;
        -  Having a cohort study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence HTAP of congenital heart disease in France.</measure>
    <time_frame>3 years</time_frame>
    <description>Number of HTAP of congenital heart disease in France after 3 years of inclusions</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">349</enrollment>
  <condition>Pulmonary Arterial Hypertension of Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>HTAP of Congenital Heart Disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with Pulmonary Arterial Hypertension of Congenital Heart Disease supported by&#xD;
        one of the 20 centers participating in the observatory during the period incusion and&#xD;
        respecting al the selection criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has a congenital heart disease other than patent foramen ovale&#xD;
&#xD;
          -  The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only&#xD;
             patients with Eisenmenger syndrome can be included without catheterization.&#xD;
&#xD;
          -  The catheterization was done after 1 January 2009&#xD;
&#xD;
          -  A mean pulmonary artery pressure &gt; 25 mm Hg&#xD;
&#xD;
          -  Pulmonary vascular resistances &gt; 3 piece Wood m2&#xD;
&#xD;
          -  Pulmonary capillary pressure available&#xD;
&#xD;
          -  Consent for inclusion in the study must be signed by parents or legal guardians for&#xD;
             minors, by the patient for adults.&#xD;
&#xD;
          -  The patient he had a surgical procedure or interventional catheterization cardiac&#xD;
             catheterization between his diagnosis and inclusion in the observatory? If yes, it can&#xD;
             only be included if a new catheterization confirmed the persistence of HTAP at least 6&#xD;
             months after the procedure.&#xD;
&#xD;
          -  Patient follow-up (at least once a year) in the center for its HTAP associated with&#xD;
             congenital heart disease its&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hopital Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.</citation>
    <PMID>22240409</PMID>
  </reference>
  <reference>
    <citation>Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.</citation>
    <PMID>22086881</PMID>
  </reference>
  <reference>
    <citation>Barst RJ, Ivy DD, Foreman AJ, McGoon MD, Rosenzweig EB. Four- and seven-year outcomes of patients with congenital heart disease-associated pulmonary arterial hypertension (from the REVEAL Registry). Am J Cardiol. 2014 Jan 1;113(1):147-55. doi: 10.1016/j.amjcard.2013.09.032. Epub 2013 Oct 4.</citation>
    <PMID>24176071</PMID>
  </reference>
  <reference>
    <citation>Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. doi: 10.1164/rccm.200510-1668OC. Epub 2006 Feb 2.</citation>
    <PMID>16456139</PMID>
  </reference>
  <reference>
    <citation>Fraisse A, Jais X, Schleich JM, di Filippo S, Maragnes P, Beghetti M, Gressin V, Voisin M, Dauphin C, Clerson P, Godart F, Bonnet D. Characteristics and prospective 2-year follow-up of children with pulmonary arterial hypertension in France. Arch Cardiovasc Dis. 2010 Feb;103(2):66-74. doi: 10.1016/j.acvd.2009.12.001. Epub 2010 Feb 11.</citation>
    <PMID>20226425</PMID>
  </reference>
  <reference>
    <citation>van Loon RL, Roofthooft MT, Hillege HL, ten Harkel AD, van Osch-Gevers M, Delhaas T, Kapusta L, Strengers JL, Rammeloo L, Clur SA, Mulder BJ, Berger RM. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005. Circulation. 2011 Oct 18;124(16):1755-64. doi: 10.1161/CIRCULATIONAHA.110.969584. Epub 2011 Sep 26.</citation>
    <PMID>21947294</PMID>
  </reference>
  <reference>
    <citation>Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. doi: 10.1016/j.ijcard.2006.09.017. Epub 2006 Dec 19.</citation>
    <PMID>17182132</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</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>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT02260362
org study id: 14126
nct id: NCT02260362
lead sponsor: 
has dmc: No
The complex congenital cardiac malformations are a significant number of different diseases,
      each having specific natural histories. The interface with pulmonary arterial hypertension
      (HTAP) is high since the physiology of many of these disorders comprises alterations in
      pulmonary vasculature.

      This observatory is a cohort of 400 patients enrolled in 3 years, older than one month,
      having been informed and have agreed to participate in the study and with congenital heart
      disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension
      confirmed by cardiac catheterization.

      The main objectives of this report are to know

        -  Incidence of congenital heart disease in HTAP France.

        -  Describe the natural history of HTAP in a large population of patients Congenital heart
           disease in France

        -  The characteristics of HTAP congenital heart disease

        -  Having a cohort study
observational model: Cohort
time perspective: Prospective
measure: Incidence HTAP of congenital heart disease in France.
time frame: 3 years
description: Number of HTAP of congenital heart disease in France after 3 years of inclusions
arm group label: HTAP of Congenital Heart Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.
PMID: 22240409
citation: Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.
PMID: 22086881
citation: Barst RJ, Ivy DD, Foreman AJ, McGoon MD, Rosenzweig EB. Four- and seven-year outcomes of patients with congenital heart disease-associated pulmonary arterial hypertension (from the REVEAL Registry). Am J Cardiol. 2014 Jan 1;113(1):147-55. doi: 10.1016/j.amjcard.2013.09.032. Epub 2013 Oct 4.
PMID: 24176071
citation: Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. doi: 10.1164/rccm.200510-1668OC. Epub 2006 Feb 2.
PMID: 16456139
citation: Fraisse A, Jais X, Schleich JM, di Filippo S, Maragnes P, Beghetti M, Gressin V, Voisin M, Dauphin C, Clerson P, Godart F, Bonnet D. Characteristics and prospective 2-year follow-up of children with pulmonary arterial hypertension in France. Arch Cardiovasc Dis. 2010 Feb;103(2):66-74. doi: 10.1016/j.acvd.2009.12.001. Epub 2010 Feb 11.
PMID: 20226425
citation: van Loon RL, Roofthooft MT, Hillege HL, ten Harkel AD, van Osch-Gevers M, Delhaas T, Kapusta L, Strengers JL, Rammeloo L, Clur SA, Mulder BJ, Berger RM. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005. Circulation. 2011 Oct 18;124(16):1755-64. doi: 10.1161/CIRCULATIONAHA.110.969584. Epub 2011 Sep 26.
PMID: 21947294
citation: Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. doi: 10.1016/j.ijcard.2006.09.017. Epub 2006 Dec 19.
PMID: 17182132
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital