xml: <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/NCT06038149</url>
    </required_header>
    <id_info>
      <org_study_id>IMPULSE</org_study_id>
      <nct_id>NCT06038149</nct_id>
    </id_info>
    <brief_title>Improving Pulmonary Hypertension Screening by Echocardiography</brief_title>
    <acronym>IMPULSE</acronym>
    <official_title>Improving Pulmonary Hypertension Screening by Echocardiography</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal United Hospitals Bath NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Janssen-Cilag Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Royal Free Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Royal Papworth Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Golden Jubilee National Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Bath</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liverpool John Moores University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Royal United Hospitals Bath NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to assess the application of the novel IMPULSE algorithm for the detection of&#xD;
        pulmonary hypertension (PH) in those with a low or intermediate probability of PH according&#xD;
        to the British Society of Echocardiography (ESC) and European Society of Cardiology (ESC)&#xD;
        guidelines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, multi-centre cross-sectional study with a planned 18 month&#xD;
        longitudinal component.&#xD;
  &#xD;
        Participants will be recruited from patients referred for the first time for transthoracic&#xD;
        echocardiography at the Royal United Hospitals Bath National Health Service (NHS) Foundation&#xD;
        Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals, Royal Papworth&#xD;
        Hospital, and Golden Jubilee Hospital.&#xD;
  &#xD;
        The investigators will prospectively recruit patients without a diagnosis of Pulmonary&#xD;
        Hypertension.&#xD;
  &#xD;
        Transthoracic echocardiographic (TTE) imaging will be performed in line with British Society&#xD;
        of Echocardiography minimum dataset guidelines, and comprehensive right heart&#xD;
        echocardiographic imaging and analysis will be performed following the British Society of&#xD;
        Echocardiography recommendations for assessing right heart function, in addition to the&#xD;
        IMPULSE algorithm;&#xD;
  &#xD;
        A right ventricular free wall longitudinal strain value of less than -23%, or, right&#xD;
        ventricular fractional area change (FAC) less than 35% in females/30% in males, in addition&#xD;
        to a right ventricular isovolumetric relaxation time in excess of 73ms in patients with&#xD;
        low/Intermediate probability of PH by current guidelines would categorise that patient as&#xD;
        being IMPULSE positive.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 19, 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension</measure>
      <time_frame>18 months</time_frame>
      <description>Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm on the assessment of PH.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analysis of the IMPULSE algorithm in comparison to existing guidlines</measure>
      <time_frame>18 months</time_frame>
      <description>Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm in comparison with the existing ESC PH guidelines.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.</measure>
      <time_frame>18 months</time_frame>
      <description>Values from echocardiographic measures of right heart systolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.</measure>
      <time_frame>18 months</time_frame>
      <description>Values from echocardiographic measures of right heart diastolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.</measure>
      <time_frame>18 months</time_frame>
      <description>Values obtained in the echocardiographic assessment of left heart disease not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Pulmonary Hypertension</condition>
    <arm_group>
      <arm_group_label>Low PH probability</arm_group_label>
      <description>Individuals identified as being of a low risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intermediate PH probability</arm_group_label>
      <description>Individuals identified as being of an intermediate risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Transthoracic echocardiogram</intervention_name>
      <description>A painless ultrasound scan of the heart.</description>
      <arm_group_label>Intermediate PH probability</arm_group_label>
      <arm_group_label>Low PH probability</arm_group_label>
      <other_name>TTE</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients referred into a UK pulmonary hypertension centre for the first time, determined to&#xD;
          be of low/intermediate probability of pulmonary hypertension on routine echocardiogram.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Unexplained breathlessness&#xD;
  &#xD;
            -  Risk factors for Pulmonary arterial hypertension (PAH), chronic thromboembolic&#xD;
               pulmonary hypertension (CTEPH)&#xD;
  &#xD;
            -  Unexplained elevation of B-type natriuretic peptide (BNP/proBNP)&#xD;
  &#xD;
            -  Referred for catheterisation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ESC / BSE echo high probability of PH&#xD;
  &#xD;
            -  Known or suspected congenital heart disease&#xD;
  &#xD;
            -  Patients unlikely to benefit from management of PH or its underlying causes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel X Augustine, BSc(Hons)</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal United Hospitall NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christopher JB Wild, BSc(Hons)</last_name>
      <phone>07891662866</phone>
      <email>chris.wild1@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jane Carter</last_name>
      <phone>01225 821095</phone>
      <email>jane.carter14@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Royal United Hospital NHS Foundation Trust</name>
        <address>
          <city>Bath</city>
          <state>Banes</state>
          <zip>BA1 3NG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Christopher JB Wild, BSc (Hons)</last_name>
        <phone>07891662866</phone>
        <email>chris.wild1@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Jane Carter</last_name>
        <phone>01225 824295</phone>
        <email>jane.carter14@nhs.net</email>
      </contact_backup>
      <investigator>
        <last_name>Daniel X Augustine, MBBS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christopher JB Wild, BSc(Hons)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jay Suntharalingham</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert Mackenzie-Ross</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Golden Jubilee Hospital</name>
        <address>
          <city>Glasgow</city>
          <state>Lanarkshire</state>
          <zip>G81 4DY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Martin Johnson</last_name>
      </contact>
      <contact_backup>
        <email>martin.johnson@ggc.scot.nhs.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Martin Johnson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
        <address>
          <city>Sheffield</city>
          <state>South Yorkshire</state>
          <zip>S10 2JF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Thanos Charalampopoulous</last_name>
        <email>athanasios.charalampopoulos@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Thanos Charalampopoulous</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Abdul Hameed</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Royal Papworth Hospital</name>
        <address>
          <city>Cambridge</city>
          <zip>CB2 0AY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Madalina Garbi</last_name>
        <email>madalina.garbi@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Madalina Garbi</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Joana Pepke-Zaba</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Royal Free NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>NW3 2QG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Gerry Coghlan</last_name>
        <email>gerry.coghlan@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Gerry Coghlan</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Daniel Knight</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Study documentation will be disseminated to all participating sites on approval.&#xD;
  All research echocardiography data will be transferred to the core lab in the Royal United Hospital Bath for analysis.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data obtained will be made available during the data collection period and transferred in batches.</ipd_time_frame>
      <ipd_access_criteria>Transfer via internal NHS DICOM servers</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038149
  org study id: IMPULSE
  nct id: NCT06038149
  lead sponsor: 
  collaborator: 
  collaborator: 
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  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study aims to assess the application of the novel IMPULSE algorithm for the detection of
        pulmonary hypertension (PH) in those with a low or intermediate probability of PH according
        to the British Society of Echocardiography (ESC) and European Society of Cardiology (ESC)
        guidelines.
  This is a prospective, multi-centre cross-sectional study with a planned 18 month
        longitudinal component.
  
        Participants will be recruited from patients referred for the first time for transthoracic
        echocardiography at the Royal United Hospitals Bath National Health Service (NHS) Foundation
        Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals, Royal Papworth
        Hospital, and Golden Jubilee Hospital.
  
        The investigators will prospectively recruit patients without a diagnosis of Pulmonary
        Hypertension.
  
        Transthoracic echocardiographic (TTE) imaging will be performed in line with British Society
        of Echocardiography minimum dataset guidelines, and comprehensive right heart
        echocardiographic imaging and analysis will be performed following the British Society of
        Echocardiography recommendations for assessing right heart function, in addition to the
        IMPULSE algorithm;
  
        A right ventricular free wall longitudinal strain value of less than -23%, or, right
        ventricular fractional area change (FAC) less than 35% in females/30% in males, in addition
        to a right ventricular isovolumetric relaxation time in excess of 73ms in patients with
        low/Intermediate probability of PH by current guidelines would categorise that patient as
        being IMPULSE positive.
  observational model: Cohort
  time perspective: Prospective
  measure: Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension
  time frame: 18 months
  description: Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm on the assessment of PH.
  measure: Analysis of the IMPULSE algorithm in comparison to existing guidlines
  time frame: 18 months
  description: Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm in comparison with the existing ESC PH guidelines.
  measure: Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.
  time frame: 18 months
  description: Values from echocardiographic measures of right heart systolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.
  measure: Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.
  time frame: 18 months
  description: Values from echocardiographic measures of right heart diastolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.
  measure: Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.
  time frame: 18 months
  description: Values obtained in the echocardiographic assessment of left heart disease not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.
  arm group label: Low PH probability
  description: Individuals identified as being of a low risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.
  arm group label: Intermediate PH probability
  description: Individuals identified as being of an intermediate risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.
  intervention type: Diagnostic Test
  intervention name: Transthoracic echocardiogram
  description: A painless ultrasound scan of the heart.
  arm group label: Intermediate PH probability
  arm group label: Low PH probability
  other name: TTE
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel X Augustine, BSc(Hons)
  role: Principal Investigator
  affiliation: Royal United Hospitall NHS Foundation Trust
  last name: Christopher JB Wild, BSc(Hons)
  phone: 07891662866
  email: chris.wild1@nhs.net
  last name: Jane Carter
  phone: 01225 821095
  email: jane.carter14@nhs.net
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
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  facility: 
  contact: 
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  investigator: 
  facility: 
  contact: 
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  facility: 
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  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Hypertension, Pulmonary
  mesh term: Hypertension
  sharing ipd: Yes
  ipd description: Study documentation will be disseminated to all participating sites on approval.
  All research echocardiography data will be transferred to the core lab in the Royal United Hospital Bath for analysis.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data obtained will be made available during the data collection period and transferred in batches.
  ipd access criteria: Transfer via internal NHS DICOM servers