<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/NCT04444973</url>
  </required_header>
  <id_info>
    <org_study_id>229599</org_study_id>
    <nct_id>NCT04444973</nct_id>
  </id_info>
  <brief_title>RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty</brief_title>
  <acronym>RVBPA</acronym>
  <official_title>Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Papworth Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic&#xD;
      pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention&#xD;
      are lacking. The investigators propose to measure right ventricular (RV) pressure volume&#xD;
      loops invasively and measure biomarkers at intervals during the course of a course of BPA.&#xD;
      These data will be analysed to define load independent indices of RV functional improvement,&#xD;
      cross correlated with biomarker data and be used to calibrate non-invasive assessment of&#xD;
      ventriculo-arterial coupling by cardiac magnetic resonance imaging (CMR) to better detect&#xD;
      responders of BPA and pulmonary endarterectomy (PEA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who have Chronic Thromboembolic Pulmonary Hypertension (CTEPH) can treated&#xD;
      surgically or by undergoing minimally invasive balloon pulmonary angioplasty (BPA). However&#xD;
      not all patients have resolution of their pulmonary hypertension following these procedures,&#xD;
      and some patients who don't have pulmonary hypertension derive substantial benefit&#xD;
      nonetheless from surgical clearance of their thromboembolic disease.&#xD;
&#xD;
      Thus better understanding of the interaction between the blood vessels, the right heart&#xD;
      workload, and symptoms and outcomes is required to predict treatment response.&#xD;
      Ventriculo-arterial coupling is one such measure, quantifying the efficiency of transfer of&#xD;
      energy from the right ventricle to the pulmonary arteries. Traditionally this has required&#xD;
      invasive procedures involving intracavity conduction catheterisation of the right ventricle&#xD;
      to simultaneously measure flow and pressure whilst altering preload. Not only is this&#xD;
      invasive, but it is not routinely performed in clinical practice due to its complexity and&#xD;
      requirement for specialised expertise and equipment. As CMR can simultaneously assess right&#xD;
      ventricular and pulmonary function it may be able to assess function and ventriculo-arterial&#xD;
      coupling non-invasively and allow for a more detailed and accessible mode of disease&#xD;
      quantification and stratification.&#xD;
&#xD;
      The investigators will measure how the right heart function changes during BPA in patients&#xD;
      with inoperable CTEPH, measured using a conductance catheter placed within the pumping&#xD;
      chamber on the right side of the heart (right ventricle). This will generate pressure volume&#xD;
      loops to detect intra-procedural changes of ventriculo-arterial coupling that can be used to&#xD;
      quantify treatment success. The investigators will also monitor the levels of a newly&#xD;
      discovered vessel inflammatory marker in the blood - Angiopoietin 2 (Ang2), and N-terminal&#xD;
      pro-brain natriuretic peptide (NT-Pro BNP) that may also be useful in identifying responders&#xD;
      to treatment and help define the optimal treatment protocol for BPA.&#xD;
&#xD;
      This participants will have CMR as standard of care. Data from CMR and invasive measurements&#xD;
      of ventriculo-arterial coupling will determine the best CMR measures of coupling efficiency.&#xD;
      These measures will then be applied within a large well-characterised cohort with long term&#xD;
      follow-up to determine its association with symptoms, and outcomes following surgical&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2022</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>Change in RV Tau</measure>
    <time_frame>3 months</time_frame>
    <description>Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ang2 an pro-NT BNP</measure>
    <time_frame>3 months</time_frame>
    <description>Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMR</measure>
    <time_frame>3 months</time_frame>
    <description>Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Invasive RV assessment</arm_group_label>
    <description>RV conductance catheter assessment of RV performance</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Balloon pulmonary angioplasty</intervention_name>
    <description>Balloon dilatation of sub segmental pulmonary artery web disease</description>
    <arm_group_label>Invasive RV assessment</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with inoperable CTEPH undergoing BPA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Inoperable CTEPH eligible for BPA treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe co-morbidity (expected life &lt;6months)&#xD;
&#xD;
          -  Women of child bearing age&#xD;
&#xD;
          -  Significant known left to right shunt&#xD;
&#xD;
          -  Permanent pacemaker&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Severe lung parenchyma disease ( eg emphysema, Interstitial Lung Disease (ILD)).&#xD;
&#xD;
          -  Retained metallic foreign body&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen P Hoole, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Papworth Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Fielding, PhD</last_name>
    <phone>+441223639960</phone>
    <email>sarah.fielding2@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Royal Papworth Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen P Hoole</last_name>
    </contact>
    <investigator>
      <last_name>Stephen P Hoole, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Balloon pulmonary angioplasty</keyword>
  <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>No</sharing_ipd>
    <ipd_description>IPD data will not be shared</ipd_description>
  </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/NCT04444973
org study id: 229599
nct id: NCT04444973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic
      pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention
      are lacking. The investigators propose to measure right ventricular (RV) pressure volume
      loops invasively and measure biomarkers at intervals during the course of a course of BPA.
      These data will be analysed to define load independent indices of RV functional improvement,
      cross correlated with biomarker data and be used to calibrate non-invasive assessment of
      ventriculo-arterial coupling by cardiac magnetic resonance imaging (CMR) to better detect
      responders of BPA and pulmonary endarterectomy (PEA).
Patients who have Chronic Thromboembolic Pulmonary Hypertension (CTEPH) can treated
      surgically or by undergoing minimally invasive balloon pulmonary angioplasty (BPA). However
      not all patients have resolution of their pulmonary hypertension following these procedures,
      and some patients who don't have pulmonary hypertension derive substantial benefit
      nonetheless from surgical clearance of their thromboembolic disease.

      Thus better understanding of the interaction between the blood vessels, the right heart
      workload, and symptoms and outcomes is required to predict treatment response.
      Ventriculo-arterial coupling is one such measure, quantifying the efficiency of transfer of
      energy from the right ventricle to the pulmonary arteries. Traditionally this has required
      invasive procedures involving intracavity conduction catheterisation of the right ventricle
      to simultaneously measure flow and pressure whilst altering preload. Not only is this
      invasive, but it is not routinely performed in clinical practice due to its complexity and
      requirement for specialised expertise and equipment. As CMR can simultaneously assess right
      ventricular and pulmonary function it may be able to assess function and ventriculo-arterial
      coupling non-invasively and allow for a more detailed and accessible mode of disease
      quantification and stratification.

      The investigators will measure how the right heart function changes during BPA in patients
      with inoperable CTEPH, measured using a conductance catheter placed within the pumping
      chamber on the right side of the heart (right ventricle). This will generate pressure volume
      loops to detect intra-procedural changes of ventriculo-arterial coupling that can be used to
      quantify treatment success. The investigators will also monitor the levels of a newly
      discovered vessel inflammatory marker in the blood - Angiopoietin 2 (Ang2), and N-terminal
      pro-brain natriuretic peptide (NT-Pro BNP) that may also be useful in identifying responders
      to treatment and help define the optimal treatment protocol for BPA.

      This participants will have CMR as standard of care. Data from CMR and invasive measurements
      of ventriculo-arterial coupling will determine the best CMR measures of coupling efficiency.
      These measures will then be applied within a large well-characterised cohort with long term
      follow-up to determine its association with symptoms, and outcomes following surgical
      intervention.
observational model: Cohort
time perspective: Prospective
measure: Change in RV Tau
time frame: 3 months
description: Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction
measure: Ang2 an pro-NT BNP
time frame: 3 months
description: Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data
measure: CMR
time frame: 3 months
description: Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data
arm group label: Invasive RV assessment
description: RV conductance catheter assessment of RV performance
intervention type: Procedure
intervention name: Balloon pulmonary angioplasty
description: Balloon dilatation of sub segmental pulmonary artery web disease
arm group label: Invasive RV assessment
Venous blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen P Hoole, MD
role: Principal Investigator
affiliation: Royal Papworth Hospital
last name: Sarah Fielding, PhD
phone: +441223639960
email: sarah.fielding2@nhs.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: No
ipd description: IPD data will not be shared