<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/NCT03243773</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2015-00133</org_study_id>
    <nct_id>NCT03243773</nct_id>
  </id_info>
  <brief_title>Evaluation of Lung Ultrasound in Acute Heart Failure</brief_title>
  <acronym>ELUSIA</acronym>
  <official_title>Evaluation of Lung UltraSound In Acute Heart Failure (ELUSIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Jörg Leuppi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hosptal, Baselland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment.&#xD;
      However, the differentiation between heart failure and other conditions presenting with acute&#xD;
      dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a&#xD;
      simple, rapid and noninvasive technique directly visualizing fluid content in the lung as&#xD;
      evidence for acute heart failure. A number of publications showed the diagnostic utility of&#xD;
      lung ultrasound in the diagnosis of heart failure, but many open questions remain.&#xD;
&#xD;
      The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a&#xD;
      cardiac origin of dyspnea in unselected patients in the emergency room as compared to&#xD;
      standard evaluation. Further goals are to evaluate if lung ultrasound provides additional&#xD;
      diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to&#xD;
      compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart&#xD;
      failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart&#xD;
      failure, age ≥75 vs &lt;75 years, women vs men and presence vs absence of concomitant pulmonary&#xD;
      disease) and to compare demographics and clinical characteristics in different patient&#xD;
      populations.&#xD;
&#xD;
      300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as&#xD;
      principal complaint will undergo initial clinical assessment of the likely etiology of&#xD;
      dyspnea by the ER physician in charge. The second assessment by the same physician will&#xD;
      include results of NT-proBNP according to predefined cutoffs. Final diagnosis (&quot;Gold&#xD;
      Standard&quot;) will be done by two experienced investigators after patient discharge taking into&#xD;
      account the complete medical record except the results of lung ultrasound. Assessment of&#xD;
      chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all&#xD;
      other results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of Lung Ultrasound in Acute Heart Failure (ELUSIA). A monocenter, randomised,&#xD;
      double-blind, diagnostic clinical study.&#xD;
&#xD;
      Background and Rationale: Acute heart failure is a life threatening condition requiring rapid&#xD;
      diagnosis and treatment. However, the differentiation between heart failure and other&#xD;
      conditions presenting with acute dyspnea is notoriously difficult in the emergency room.&#xD;
      Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly&#xD;
      visualizing fluid content in the lung as evidence for acute heart failure. A number of&#xD;
      publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart&#xD;
      failure, but many open questions remain.&#xD;
&#xD;
      Objective(s): 1) To evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac&#xD;
      origin of dyspnea in unselected patients in the emergency room as compared to standard&#xD;
      evaluation. 2) To evaluate if lung ultrasound provides additional diagnostic information as&#xD;
      compared to clinical examination, NT-proBNP and chest X-ray. 3) To compare the diagnostic&#xD;
      accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs&#xD;
      reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs &lt;75&#xD;
      years, women vs men and presence vs absence of concomitant pulmonary disease. 4) To compare&#xD;
      demographics and clinical characteristics in different patient populations.&#xD;
&#xD;
      Inclusion criteria: Emergency room presentation with acute dyspnoe as principal complaint&#xD;
      (either new or worsening in the last 48 hours), age ≥18 years.&#xD;
&#xD;
      Exclusion criteria: Immediately life threatening condition (cardiac arrest, ST-elevation&#xD;
      myocardial infarction, shock, respiratory failure requiring intubation), no consent.&#xD;
&#xD;
      Measurements and Procedures: Initial clinical assessment of the likely etiology of dyspnea by&#xD;
      the emergency room physician in charge. Second assessment by the same physician including&#xD;
      results of NT-proBNP according to predefined cutoffs. Final diagnosis (&quot;Gold Standard&quot;)&#xD;
      considering the complete medical record except the results of lung ultrasound by 2&#xD;
      experienced investigators after patient discharge. Assessment of chest X-ray and lung&#xD;
      ultrasound by investigators blinded regarding all other results.&#xD;
&#xD;
      Study Product/Intervention: Point-of-care lung ultrasound in the emergency room as only study&#xD;
      specific intervention. Registration of &quot;B-lines&quot; in 4 defined zones on both sides and&#xD;
      calculation of a validated score. Digital storing of results for offline analysis.&#xD;
&#xD;
      Comparator(s): Comparison of the accuracy of lung ultrasound for the diagnosis of acute heart&#xD;
      failure as compared to clinical investigation, NT-proBNP and chest X-ray alone or in&#xD;
      combination.&#xD;
&#xD;
      Number of Participants: 300 patients. Based on the literature and clinical expericence we&#xD;
      estimate than at least 50% of the patients will have a diagnosis of heart failure. In this&#xD;
      group around 50% of patients will have heart failure with preserved, the other 50% with&#xD;
      reduced ejection fraction. Most patients will suffer from decompensation of chronic heart&#xD;
      failure and will be older than 75 years. Around 1/3 of the patients will have an additional&#xD;
      diagnosis of chronic lung disease.&#xD;
&#xD;
      Study Duration: 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>Value of lung ultrasound in the diagnosis of acute heart failure</measure>
    <time_frame>at the time of inclusion into the study</time_frame>
    <description>Presence/Absence of heart failure</description>
  </primary_outcome>
  <enrollment type="Actual">56</enrollment>
  <condition>Acute Heart Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung ultrasound</intervention_name>
    <description>Point-of-care ultrasound exam of both lungs in 4 predefined zones.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Standard laboratory samples for blood cell count, blood chemistry including NT-proBNP&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Unselected patients presenting with this acute dyspnea to the emergency department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Emergency room presentation with acute dyspnoe as principal complaint (either new or&#xD;
        worsening in the last 48 hours) Age ≥18 years.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Immediately life threatening condition (cardiac arrest, ST-elevation myocardial infarction,&#xD;
        shock, respiratory failure requiring intubation) No consent.&#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>Peter Rickenbacher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital Baselland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cantonal Hospital Baselland</name>
      <address>
        <city>Bruderholz</city>
        <state>BL</state>
        <zip>4101</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hosptal, Baselland</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Jörg Leuppi</investigator_full_name>
    <investigator_title>Institutional Head</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_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/NCT03243773
org study id: BASEC 2015-00133
nct id: NCT03243773
lead sponsor: 
has dmc: Yes
Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment.
      However, the differentiation between heart failure and other conditions presenting with acute
      dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a
      simple, rapid and noninvasive technique directly visualizing fluid content in the lung as
      evidence for acute heart failure. A number of publications showed the diagnostic utility of
      lung ultrasound in the diagnosis of heart failure, but many open questions remain.

      The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a
      cardiac origin of dyspnea in unselected patients in the emergency room as compared to
      standard evaluation. Further goals are to evaluate if lung ultrasound provides additional
      diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to
      compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart
      failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart
      failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary
      disease) and to compare demographics and clinical characteristics in different patient
      populations.

      300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as
      principal complaint will undergo initial clinical assessment of the likely etiology of
      dyspnea by the ER physician in charge. The second assessment by the same physician will
      include results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold
      Standard") will be done by two experienced investigators after patient discharge taking into
      account the complete medical record except the results of lung ultrasound. Assessment of
      chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all
      other results.
Evaluation of Lung Ultrasound in Acute Heart Failure (ELUSIA). A monocenter, randomised,
      double-blind, diagnostic clinical study.

      Background and Rationale: Acute heart failure is a life threatening condition requiring rapid
      diagnosis and treatment. However, the differentiation between heart failure and other
      conditions presenting with acute dyspnea is notoriously difficult in the emergency room.
      Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly
      visualizing fluid content in the lung as evidence for acute heart failure. A number of
      publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart
      failure, but many open questions remain.

      Objective(s): 1) To evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac
      origin of dyspnea in unselected patients in the emergency room as compared to standard
      evaluation. 2) To evaluate if lung ultrasound provides additional diagnostic information as
      compared to clinical examination, NT-proBNP and chest X-ray. 3) To compare the diagnostic
      accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs
      reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75
      years, women vs men and presence vs absence of concomitant pulmonary disease. 4) To compare
      demographics and clinical characteristics in different patient populations.

      Inclusion criteria: Emergency room presentation with acute dyspnoe as principal complaint
      (either new or worsening in the last 48 hours), age ≥18 years.

      Exclusion criteria: Immediately life threatening condition (cardiac arrest, ST-elevation
      myocardial infarction, shock, respiratory failure requiring intubation), no consent.

      Measurements and Procedures: Initial clinical assessment of the likely etiology of dyspnea by
      the emergency room physician in charge. Second assessment by the same physician including
      results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold Standard")
      considering the complete medical record except the results of lung ultrasound by 2
      experienced investigators after patient discharge. Assessment of chest X-ray and lung
      ultrasound by investigators blinded regarding all other results.

      Study Product/Intervention: Point-of-care lung ultrasound in the emergency room as only study
      specific intervention. Registration of "B-lines" in 4 defined zones on both sides and
      calculation of a validated score. Digital storing of results for offline analysis.

      Comparator(s): Comparison of the accuracy of lung ultrasound for the diagnosis of acute heart
      failure as compared to clinical investigation, NT-proBNP and chest X-ray alone or in
      combination.

      Number of Participants: 300 patients. Based on the literature and clinical expericence we
      estimate than at least 50% of the patients will have a diagnosis of heart failure. In this
      group around 50% of patients will have heart failure with preserved, the other 50% with
      reduced ejection fraction. Most patients will suffer from decompensation of chronic heart
      failure and will be older than 75 years. Around 1/3 of the patients will have an additional
      diagnosis of chronic lung disease.

      Study Duration: 3 years.
observational model: Cohort
time perspective: Prospective
measure: Value of lung ultrasound in the diagnosis of acute heart failure
time frame: at the time of inclusion into the study
description: Presence/Absence of heart failure
intervention type: Other
intervention name: Lung ultrasound
description: Point-of-care ultrasound exam of both lungs in 4 predefined zones.
Standard laboratory samples for blood cell count, blood chemistry including NT-proBNP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Rickenbacher, MD
role: Principal Investigator
affiliation: Cantonal Hospital Baselland
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Cantonal Hosptal, Baselland
investigator full name: Prof. Dr. Jörg Leuppi
investigator title: Institutional Head
mesh term: Heart Failure
sharing ipd: No