<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/NCT04472533</url>
  </required_header>
  <id_info>
    <org_study_id>T01502</org_study_id>
    <nct_id>NCT04472533</nct_id>
  </id_info>
  <brief_title>Serum Bio-markers in Pulmonary Hypertension</brief_title>
  <official_title>Role of Inflammation and Angiogenesis in Chronic Thromboembolic Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Papworth Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Papworth Hospital NHS Foundation Trust</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>
      Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by scarred blood clots in the&#xD;
      blood vessels supplying the lungs. This in turn leads to failure of the right side of the&#xD;
      heart. The reason why these scarred clots form is unknown. An operation to remove the scarred&#xD;
      clots, known as pulmonary endarterectomy, is a potential cure. However, some patients have&#xD;
      persistent obstructions within the blood vessels and heart failure even after surgery.&#xD;
&#xD;
      It is thought that abnormal levels of proteins, found in the blood stream and responsible for&#xD;
      inflammation and the development of new blood vessels may have role in causing the disease.&#xD;
      In this study, these proteins were measured to assess whether they provide clues as to the&#xD;
      cause of the disease and whether they could be used for the risk stratification of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic thromboembolic pulmonary hypertension (CTEPH) is an underdiagnosed form of pulmonary&#xD;
      hypertension whose pathogenesis remains to be fully elucidated. Altered endothelial&#xD;
      homeostasis, defective angiogenesis and inflammation have been implicated. The formation of&#xD;
      the organised occlusions is considered to arise from a failure to resolve acute pulmonary&#xD;
      emboli. There is emerging evidence supporting the role of mediators of angiogenesis,&#xD;
      inflammation and the coagulation cascade (and their many interactions) in CTEPH. Pulmonary&#xD;
      endarterectomy (PEA), to remove these occlusions, may be a cure in some patients. Assessing&#xD;
      circulating proteins associated with these processes may be not only useful for understanding&#xD;
      disease pathogenesis but may also lead to improvements in clinical assessment.&#xD;
&#xD;
      The study was approved by the Regional Ethics Committee (Papworth Hospital Research Tissue&#xD;
      Bank; 08/H0304/56+5). Consecutive patients undergoing PEA surgery at Royal Papworth Hospital&#xD;
      National Health Service Foundation Trust, United Kingdom, who consented for participation in&#xD;
      the Research Tissue Bank between February 2012 and August 2014, were recruited. A validation&#xD;
      data set included all consecutive samples collected from CTEPH patients prior to PEA between&#xD;
      April 2010 and Aug 2017. Patients were diagnosed in accordance with international guidelines.&#xD;
&#xD;
      Patients had serum samples collected from a peripheral vein prior to PEA. In a subset of&#xD;
      patients, further sampling was performed at the first follow up visit to Papworth Hospital&#xD;
      3-6 months post-PEA. Customized human cytokine/chemokine magnetic bead assays and customized&#xD;
      human angiogenesis/growth factor assays were used to measure levels of circulating proteins&#xD;
      in these serum samples (interleukin [IL] 6, IL8, IL10, tumour necrosis factor [TNF] α,&#xD;
      angiopoietin 2 [Ang2], endoglin, vascular endothelial growth factor [VEGF] a, VEGFc, VEGFd&#xD;
      and bone morphogenetic protein 9 [BMP9]).&#xD;
&#xD;
      Levels were compared to levels from patients with chronic thromboembolic disease but no&#xD;
      pulmonary hypertension (CTED) and healthy age and sex matched controls. In addition&#xD;
      multivariate rank regression models were used to assess associations between levels of&#xD;
      circulating proteins and clinical assessments carried out as part of the patients routine&#xD;
      clinical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2012</start_date>
  <completion_date type="Actual">October 26, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>Assess the differences between circulating biomarkers between patients with CTEPH, CTED and controls</measure>
    <time_frame>24 hours</time_frame>
    <description>Assess differences in inflammatory cytokines (IL6, 8, 10, TNFa, hsCRP [all measured in pg/ml]) and markers of angiogenesis (Ang2, BMP9, Endoglin, VEGFa, VEGFc, VEGFd [all measured in pg/ml]) in patients with CTEPH compared to healthy controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between IL6 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum IL6 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between IL8 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum IL8 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between IL10 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum IL10 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between TNFa and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum TNFa and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between Ang2 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum Ang2 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between BMP9 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum BMP9 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between Endoglin and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum Endoglin and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between VEGFa and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum VEGFa and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between VEGFc and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum VEGFc and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between VEGFd and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum VEGFd and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess associations, using multivariate regression modelling, between hsCRP and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH</measure>
    <time_frame>24 hours</time_frame>
    <description>Using multivariate rank regression modelling, associations between serum hsCRP and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">377</enrollment>
  <condition>Pulmonary Hypertension, Primary, 4</condition>
  <arm_group>
    <arm_group_label>CTEPH</arm_group_label>
    <description>Patients diagnosed with chronic thromboembolic pulmonary hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTED</arm_group_label>
    <description>Patients diagnosed with chronic thromboembolic disease but no evidence of pulmonary hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy control subjects</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with CTEPH, CTED and healthy control volunteers at the Royal Papworth&#xD;
        Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients able to give informed written consent&#xD;
&#xD;
          -  Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)&#xD;
             according to international guidelines at an expert pulmonary hypertension centre&#xD;
&#xD;
          -  Patients diagnosed with chronic thromboembolic disease (CTED) according to&#xD;
             international guidelines at an expert pulmonary hypertension centre&#xD;
&#xD;
          -  Age and sex matched healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with inflammatory comorbidities&#xD;
&#xD;
          -  Patients taking immunosuppressant medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanna Pepke-Zaba, PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Papworth Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Papworth Hospital NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.</citation>
    <PMID>26320113</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inflammation</keyword>
  <keyword>angiogenesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>October 27, 2022</submitted>
    <returned>September 7, 2023</returned>
  </pending_results>
  <!-- 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/NCT04472533
org study id: T01502
nct id: NCT04472533
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by scarred blood clots in the
      blood vessels supplying the lungs. This in turn leads to failure of the right side of the
      heart. The reason why these scarred clots form is unknown. An operation to remove the scarred
      clots, known as pulmonary endarterectomy, is a potential cure. However, some patients have
      persistent obstructions within the blood vessels and heart failure even after surgery.

      It is thought that abnormal levels of proteins, found in the blood stream and responsible for
      inflammation and the development of new blood vessels may have role in causing the disease.
      In this study, these proteins were measured to assess whether they provide clues as to the
      cause of the disease and whether they could be used for the risk stratification of patients.
Chronic thromboembolic pulmonary hypertension (CTEPH) is an underdiagnosed form of pulmonary
      hypertension whose pathogenesis remains to be fully elucidated. Altered endothelial
      homeostasis, defective angiogenesis and inflammation have been implicated. The formation of
      the organised occlusions is considered to arise from a failure to resolve acute pulmonary
      emboli. There is emerging evidence supporting the role of mediators of angiogenesis,
      inflammation and the coagulation cascade (and their many interactions) in CTEPH. Pulmonary
      endarterectomy (PEA), to remove these occlusions, may be a cure in some patients. Assessing
      circulating proteins associated with these processes may be not only useful for understanding
      disease pathogenesis but may also lead to improvements in clinical assessment.

      The study was approved by the Regional Ethics Committee (Papworth Hospital Research Tissue
      Bank; 08/H0304/56+5). Consecutive patients undergoing PEA surgery at Royal Papworth Hospital
      National Health Service Foundation Trust, United Kingdom, who consented for participation in
      the Research Tissue Bank between February 2012 and August 2014, were recruited. A validation
      data set included all consecutive samples collected from CTEPH patients prior to PEA between
      April 2010 and Aug 2017. Patients were diagnosed in accordance with international guidelines.

      Patients had serum samples collected from a peripheral vein prior to PEA. In a subset of
      patients, further sampling was performed at the first follow up visit to Papworth Hospital
      3-6 months post-PEA. Customized human cytokine/chemokine magnetic bead assays and customized
      human angiogenesis/growth factor assays were used to measure levels of circulating proteins
      in these serum samples (interleukin [IL] 6, IL8, IL10, tumour necrosis factor [TNF] α,
      angiopoietin 2 [Ang2], endoglin, vascular endothelial growth factor [VEGF] a, VEGFc, VEGFd
      and bone morphogenetic protein 9 [BMP9]).

      Levels were compared to levels from patients with chronic thromboembolic disease but no
      pulmonary hypertension (CTED) and healthy age and sex matched controls. In addition
      multivariate rank regression models were used to assess associations between levels of
      circulating proteins and clinical assessments carried out as part of the patients routine
      clinical care.
observational model: Cohort
time perspective: Prospective
measure: Assess the differences between circulating biomarkers between patients with CTEPH, CTED and controls
time frame: 24 hours
description: Assess differences in inflammatory cytokines (IL6, 8, 10, TNFa, hsCRP [all measured in pg/ml]) and markers of angiogenesis (Ang2, BMP9, Endoglin, VEGFa, VEGFc, VEGFd [all measured in pg/ml]) in patients with CTEPH compared to healthy controls
measure: Assess associations, using multivariate regression modelling, between IL6 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum IL6 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between IL8 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum IL8 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between IL10 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum IL10 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between TNFa and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum TNFa and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between Ang2 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum Ang2 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between BMP9 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum BMP9 and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between Endoglin and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum Endoglin and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between VEGFa and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum VEGFa and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between VEGFc and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum VEGFc and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between VEGFd and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum VEGFd and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
measure: Assess associations, using multivariate regression modelling, between hsCRP and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH
time frame: 24 hours
description: Using multivariate rank regression modelling, associations between serum hsCRP and clinical assessments (pulmonary haemodynamics, functional class, six-minute walk test distance) performed in patients with CTEPH prior to pulmonary endarterectomy will be assessed. Adjustments will be made to correct for multiple testing.
arm group label: CTEPH
description: Patients diagnosed with chronic thromboembolic pulmonary hypertension
arm group label: CTED
description: Patients diagnosed with chronic thromboembolic disease but no evidence of pulmonary hypertension
arm group label: Control
description: Healthy control subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joanna Pepke-Zaba, PhD FRCP
role: Principal Investigator
affiliation: Royal Papworth Hospital NHS Foundation Trust
facility: 
country: United Kingdom
citation: Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
PMID: 26320113
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension
sharing ipd: No
ipd description: No plan to share individual participant data
submitted: October 27, 2022
returned: September 7, 2023