<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/NCT04499196</url>
  </required_header>
  <id_info>
    <org_study_id>LD2020</org_study_id>
    <nct_id>NCT04499196</nct_id>
  </id_info>
  <brief_title>Glucocorticoids and Pulmonary Hypertension</brief_title>
  <official_title>Prospective Study of Glucocorticoids as a Mechanism to Treat Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      Pediatric idiopathic pulmonary hypertension has significant morbidity and mortality. An ever&#xD;
      expanding body of knowledge indicates the important contribution of inflammation to&#xD;
      pathogenesis and successful treatment with glucocorticoids. Over the last several years the&#xD;
      investigators have utilized steroids in patients with severe pulmonary hypertension as part&#xD;
      of a treatment regimen. These basic science studies possibly identifies a biochemical&#xD;
      etiology for the development of disease and may also be impacted by the administration of&#xD;
      steroids. Additionally, there is a commercially available assay which tests for all of the&#xD;
      above molecules.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">July 29, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 29, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Echo estimation of RV pressure</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pulmonary Hypertension Due to Lung Diseases and Hypoxia</condition>
  <condition>Pulmonary Hypertension</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GlucoCorticoid</intervention_name>
    <description>Administering glucocorticoid</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        neonates with BPD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  premature, BPD, &gt;36 wga&#xD;
&#xD;
          -  pulmonary hypertension evidence by echocardiogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor ventilation/oxygenation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manish Aggarwal, MD</last_name>
    <phone>314-273-8329</phone>
    <email>maggarwal@wustl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ronald M Grady, MD</last_name>
    <phone>314-454-6095</phone>
    <email>rmgrady@wustl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Louis Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manish Aggarwal, MD</last_name>
      <phone>314-454-6095</phone>
      <email>maggarwal@wustl.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tuder RM, Groves B, Badesch DB, Voelkel NF. Exuberant endothelial cell growth and elements of inflammation are present in plexiform lesions of pulmonary hypertension. Am J Pathol. 1994 Feb;144(2):275-85.</citation>
    <PMID>7508683</PMID>
  </reference>
  <reference>
    <citation>Perros F, Dorfmuller P, Montani D, Hammad H, Waelput W, Girerd B, Raymond N, Mercier O, Mussot S, Cohen-Kaminsky S, Humbert M, Lambrecht BN. Pulmonary lymphoid neogenesis in idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Feb 1;185(3):311-21. doi: 10.1164/rccm.201105-0927OC. Epub 2011 Nov 22.</citation>
    <PMID>22108206</PMID>
  </reference>
  <reference>
    <citation>Savai R, Pullamsetti SS, Kolbe J, Bieniek E, Voswinckel R, Fink L, Scheed A, Ritter C, Dahal BK, Vater A, Klussmann S, Ghofrani HA, Weissmann N, Klepetko W, Banat GA, Seeger W, Grimminger F, Schermuly RT. Immune and inflammatory cell involvement in the pathology of idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Nov 1;186(9):897-908. doi: 10.1164/rccm.201202-0335OC. Epub 2012 Sep 6.</citation>
    <PMID>22955318</PMID>
  </reference>
  <reference>
    <citation>Stenmark KR, Meyrick B, Galie N, Mooi WJ, McMurtry IF. Animal models of pulmonary arterial hypertension: the hope for etiological discovery and pharmacological cure. Am J Physiol Lung Cell Mol Physiol. 2009 Dec;297(6):L1013-32. doi: 10.1152/ajplung.00217.2009. Epub 2009 Sep 11.</citation>
    <PMID>19748998</PMID>
  </reference>
  <reference>
    <citation>Langleben D, Reid LM. Effect of methylprednisolone on monocrotaline-induced pulmonary vascular disease and right ventricular hypertrophy. Lab Invest. 1985 Mar;52(3):298-303.</citation>
    <PMID>3156262</PMID>
  </reference>
  <reference>
    <citation>Wang W, Wang YL, Chen XY, Li YT, Hao W, Jin YP, Han B. Dexamethasone attenuates development of monocrotaline-induced pulmonary arterial hypertension. Mol Biol Rep. 2011 Jun;38(5):3277-84. doi: 10.1007/s11033-010-0390-x. Epub 2011 Mar 23.</citation>
    <PMID>21431360</PMID>
  </reference>
  <reference>
    <citation>Ogawa A, Nakamura K, Mizoguchi H, Fujii N, Fujio H, Kusano KF, Ohe T, Ito H. Prednisolone ameliorates idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2011 Jan 1;183(1):139-40. doi: 10.1164/ajrccm.183.1.139. No abstract available.</citation>
    <PMID>21193794</PMID>
  </reference>
  <reference>
    <citation>Ogawa A, Nakamura K, Matsubara H, Fujio H, Ikeda T, Kobayashi K, Miyazaki I, Asanuma M, Miyaji K, Miura D, Kusano KF, Date H, Ohe T. Prednisolone inhibits proliferation of cultured pulmonary artery smooth muscle cells of patients with idiopathic pulmonary arterial hypertension. Circulation. 2005 Sep 20;112(12):1806-12. doi: 10.1161/CIRCULATIONAHA.105.536169. Epub 2005 Sep 12. Erratum In: Circulation. 2006 Apr 18;113(15):e713.</citation>
    <PMID>16157769</PMID>
  </reference>
  <reference>
    <citation>Aggarwal M, Grady RM. Glucocorticoids for treating paediatric pulmonary hypertension: a novel use for a common medication. Cardiol Young. 2017 Sep;27(7):1410-1412. doi: 10.1017/S1047951117000464. Epub 2017 May 16.</citation>
    <PMID>28506331</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 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>Lung Diseases</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_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/NCT04499196
org study id: LD2020
nct id: NCT04499196
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pediatric idiopathic pulmonary hypertension has significant morbidity and mortality. An ever
      expanding body of knowledge indicates the important contribution of inflammation to
      pathogenesis and successful treatment with glucocorticoids. Over the last several years the
      investigators have utilized steroids in patients with severe pulmonary hypertension as part
      of a treatment regimen. These basic science studies possibly identifies a biochemical
      etiology for the development of disease and may also be impacted by the administration of
      steroids. Additionally, there is a commercially available assay which tests for all of the
      above molecules.
observational model: Case-Only
time perspective: Prospective
measure: Echo estimation of RV pressure
time frame: 5 days
intervention type: Drug
intervention name: GlucoCorticoid
description: Administering glucocorticoid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 5 Years
healthy volunteers: No
last name: Manish Aggarwal, MD
phone: 314-273-8329
email: maggarwal@wustl.edu
last name: Ronald M Grady, MD
phone: 314-454-6095
email: rmgrady@wustl.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Tuder RM, Groves B, Badesch DB, Voelkel NF. Exuberant endothelial cell growth and elements of inflammation are present in plexiform lesions of pulmonary hypertension. Am J Pathol. 1994 Feb;144(2):275-85.
PMID: 7508683
citation: Perros F, Dorfmuller P, Montani D, Hammad H, Waelput W, Girerd B, Raymond N, Mercier O, Mussot S, Cohen-Kaminsky S, Humbert M, Lambrecht BN. Pulmonary lymphoid neogenesis in idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Feb 1;185(3):311-21. doi: 10.1164/rccm.201105-0927OC. Epub 2011 Nov 22.
PMID: 22108206
citation: Savai R, Pullamsetti SS, Kolbe J, Bieniek E, Voswinckel R, Fink L, Scheed A, Ritter C, Dahal BK, Vater A, Klussmann S, Ghofrani HA, Weissmann N, Klepetko W, Banat GA, Seeger W, Grimminger F, Schermuly RT. Immune and inflammatory cell involvement in the pathology of idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Nov 1;186(9):897-908. doi: 10.1164/rccm.201202-0335OC. Epub 2012 Sep 6.
PMID: 22955318
citation: Stenmark KR, Meyrick B, Galie N, Mooi WJ, McMurtry IF. Animal models of pulmonary arterial hypertension: the hope for etiological discovery and pharmacological cure. Am J Physiol Lung Cell Mol Physiol. 2009 Dec;297(6):L1013-32. doi: 10.1152/ajplung.00217.2009. Epub 2009 Sep 11.
PMID: 19748998
citation: Langleben D, Reid LM. Effect of methylprednisolone on monocrotaline-induced pulmonary vascular disease and right ventricular hypertrophy. Lab Invest. 1985 Mar;52(3):298-303.
PMID: 3156262
citation: Wang W, Wang YL, Chen XY, Li YT, Hao W, Jin YP, Han B. Dexamethasone attenuates development of monocrotaline-induced pulmonary arterial hypertension. Mol Biol Rep. 2011 Jun;38(5):3277-84. doi: 10.1007/s11033-010-0390-x. Epub 2011 Mar 23.
PMID: 21431360
citation: Ogawa A, Nakamura K, Mizoguchi H, Fujii N, Fujio H, Kusano KF, Ohe T, Ito H. Prednisolone ameliorates idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2011 Jan 1;183(1):139-40. doi: 10.1164/ajrccm.183.1.139. No abstract available.
PMID: 21193794
citation: Ogawa A, Nakamura K, Matsubara H, Fujio H, Ikeda T, Kobayashi K, Miyazaki I, Asanuma M, Miyaji K, Miura D, Kusano KF, Date H, Ohe T. Prednisolone inhibits proliferation of cultured pulmonary artery smooth muscle cells of patients with idiopathic pulmonary arterial hypertension. Circulation. 2005 Sep 20;112(12):1806-12. doi: 10.1161/CIRCULATIONAHA.105.536169. Epub 2005 Sep 12. Erratum In: Circulation. 2006 Apr 18;113(15):e713.
PMID: 16157769
citation: Aggarwal M, Grady RM. Glucocorticoids for treating paediatric pulmonary hypertension: a novel use for a common medication. Cardiol Young. 2017 Sep;27(7):1410-1412. doi: 10.1017/S1047951117000464. Epub 2017 May 16.
PMID: 28506331
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Hypertension, Pulmonary
mesh term: Bronchopulmonary Dysplasia
mesh term: Hypertension
mesh term: Hypoxia
mesh term: Glucocorticoids
sharing ipd: No