<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/NCT02969486</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00747</org_study_id>
    <nct_id>NCT02969486</nct_id>
  </id_info>
  <brief_title>Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography</brief_title>
  <acronym>PAP-EIT</acronym>
  <official_title>Prospective Proof-of-concept Study Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in&#xD;
      pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is&#xD;
      fatal in absence of adequate treatment or therapy, as the condition progressively increases&#xD;
      the workload of the right heart and ultimately leads to its failure. With a minimal&#xD;
      indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone.&#xD;
      After initiation of PH therapy, the follow-up of the patient's health status is often limited&#xD;
      to punctual PAP measurements at the clinic at intervals of several months. The lack of more&#xD;
      frequent measurements of the patient's PAP strongly hinders the identification of short-term&#xD;
      trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or&#xD;
      treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such&#xD;
      as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced&#xD;
      for the continuous monitoring of PAP in patients with PH. The benefits of frequent&#xD;
      measurements over intermittent clinic visits have been demonstrated in several previous&#xD;
      studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart&#xD;
      failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless,&#xD;
      despite the undeniable advantages that implantable monitors offer to the patient, they remain&#xD;
      highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP&#xD;
      exist, such as transthoracic echocardiography, but are impractical for frequent PAP&#xD;
      assessments due to their dependency on qualified personnel to perform the measurement. An&#xD;
      optimal PAP monitoring modality for patients with PH should be non-invasive (free of any&#xD;
      risks or complications associated with cardiac catheterization) and unsupervised (able to&#xD;
      operate without supervision of a medical doctor). Such a modality does not currently exist.&#xD;
      In the present study, the investigators propose and investigate the potential of a novel&#xD;
      non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave&#xD;
      velocity (PWV) principle and the use of electrical impedance tomography (EIT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation coefficients</measure>
    <time_frame>Single visit 2 hours</time_frame>
    <description>Assessment of significant subject-wise correlation coefficients between the reference PAP, obtained by the gold Standard transthoracic echocardiography technique, and an EIT-derived PAP-related parameter. The primary outcome is therefore the demonstration of the feasibility of monitoring changes in PAP (intra-subject trending ability) by EIT.</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Pulmonary Artery Pressure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects ≥ 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects ≥ 18 years old, BMI &lt; 30 kg/m2&#xD;
&#xD;
          -  Good understanding of written and oral German&#xD;
&#xD;
          -  Willing to provide a signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pace-maker/ ICD&#xD;
&#xD;
          -  Chronic heart diseases&#xD;
&#xD;
          -  Chronic pulmonary diseases&#xD;
&#xD;
          -  Congenital heart/pulmonary diseases&#xD;
&#xD;
          -  Instable angina pectoris&#xD;
&#xD;
          -  Active alcohol or drug abuse&#xD;
&#xD;
          -  Pregnancy or lactation (women of childbearing age will be asked to performed urinary&#xD;
             pregnancy test before the screening phase)&#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>Stefano Rimoldi, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</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>
  <reference>
    <citation>Strange G, Playford D, Stewart S, Deague JA, Nelson H, Kent A, Gabbay E. Pulmonary hypertension: prevalence and mortality in the Armadale echocardiography cohort. Heart. 2012 Dec;98(24):1805-11. doi: 10.1136/heartjnl-2012-301992. Epub 2012 Jul 3.</citation>
    <PMID>22760869</PMID>
  </reference>
  <reference>
    <citation>McGoon MD, Kane GC. Pulmonary hypertension: diagnosis and management. Mayo Clin Proc. 2009 Feb;84(2):191-207. doi: 10.1016/S0025-6196(11)60828-8. Erratum In: Mayo Clin Proc. 2009 Apr;84(4):386.</citation>
    <PMID>19181654</PMID>
  </reference>
  <reference>
    <citation>Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3. Erratum In: Lancet. 2012 Feb 4;379(9814):412.</citation>
    <PMID>21315441</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02969486
org study id: 2016-00747
nct id: NCT02969486
lead sponsor: 
has dmc: Yes
Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in
      pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is
      fatal in absence of adequate treatment or therapy, as the condition progressively increases
      the workload of the right heart and ultimately leads to its failure. With a minimal
      indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone.
      After initiation of PH therapy, the follow-up of the patient's health status is often limited
      to punctual PAP measurements at the clinic at intervals of several months. The lack of more
      frequent measurements of the patient's PAP strongly hinders the identification of short-term
      trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or
      treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such
      as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced
      for the continuous monitoring of PAP in patients with PH. The benefits of frequent
      measurements over intermittent clinic visits have been demonstrated in several previous
      studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart
      failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless,
      despite the undeniable advantages that implantable monitors offer to the patient, they remain
      highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP
      exist, such as transthoracic echocardiography, but are impractical for frequent PAP
      assessments due to their dependency on qualified personnel to perform the measurement. An
      optimal PAP monitoring modality for patients with PH should be non-invasive (free of any
      risks or complications associated with cardiac catheterization) and unsupervised (able to
      operate without supervision of a medical doctor). Such a modality does not currently exist.
      In the present study, the investigators propose and investigate the potential of a novel
      non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave
      velocity (PWV) principle and the use of electrical impedance tomography (EIT).
observational model: Other
time perspective: Prospective
measure: Correlation coefficients
time frame: Single visit 2 hours
description: Assessment of significant subject-wise correlation coefficients between the reference PAP, obtained by the gold Standard transthoracic echocardiography technique, and an EIT-derived PAP-related parameter. The primary outcome is therefore the demonstration of the feasibility of monitoring changes in PAP (intra-subject trending ability) by EIT.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stefano Rimoldi, Prof
role: Study Director
affiliation: Insel Gruppe AG, University Hospital Bern
facility: 
country: Switzerland
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
citation: Strange G, Playford D, Stewart S, Deague JA, Nelson H, Kent A, Gabbay E. Pulmonary hypertension: prevalence and mortality in the Armadale echocardiography cohort. Heart. 2012 Dec;98(24):1805-11. doi: 10.1136/heartjnl-2012-301992. Epub 2012 Jul 3.
PMID: 22760869
citation: McGoon MD, Kane GC. Pulmonary hypertension: diagnosis and management. Mayo Clin Proc. 2009 Feb;84(2):191-207. doi: 10.1016/S0025-6196(11)60828-8. Erratum In: Mayo Clin Proc. 2009 Apr;84(4):386.
PMID: 19181654
citation: Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3. Erratum In: Lancet. 2012 Feb 4;379(9814):412.
PMID: 21315441
responsible party type: Sponsor
sharing ipd: No