<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/NCT03262571</url>
  </required_header>
  <id_info>
    <org_study_id>B-LINES</org_study_id>
    <nct_id>NCT03262571</nct_id>
  </id_info>
  <brief_title>Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure</brief_title>
  <official_title>Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to&#xD;
      physical examination, leads to a reduction of the admission rate for acute decompensated&#xD;
      heart failure of patients with chronic heart failure (HF) followed in the outpatients heart&#xD;
      failure clinic.&#xD;
&#xD;
      Methods. This is a prospective randomized study. The planned sample size consists of 440&#xD;
      patients with chronic HF.&#xD;
&#xD;
      The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed&#xD;
      written informed consent (3) history of HF for at least six months, (4) left ventricular&#xD;
      ejection fraction &lt; 45%, (5) adequate medical therapy for HF for at least two months.&#xD;
&#xD;
      The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or&#xD;
      treatment with experimental drugs or devices within 30 days of clinical assessment, (2)&#xD;
      inability to undergo to the planned follow-up and procedures (3) documented pulmonary&#xD;
      infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease&#xD;
      according to GOLD classification.&#xD;
&#xD;
      Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and&#xD;
      physical examination; and group B, patients undergoing to physical examination only. Patients&#xD;
      are evaluated at baseline and after three months with medical history, Quality of Life test,&#xD;
      physical examination, blood sample for hematochemical (creatinine, electrolytes,&#xD;
      BNP/NTpro-BNP).&#xD;
&#xD;
      The diuretic therapy is then optimized according to the presence and severity of B-lines in&#xD;
      group A and physical examination in group B.&#xD;
&#xD;
      Only patients enrolled in group A undergo to a lung ultrasound examination to assess the&#xD;
      extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the&#xD;
      contrast between air-filled structures and water-thickened pulmonary interlobular septa. This&#xD;
      leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in&#xD;
      the screen. The ultrasound examination is performed with a handheld echocardiography device.&#xD;
      The physician carries out a scan of the pulmonary fields, from basal towards mid and apical&#xD;
      fields, through the midaxillary line while the patient lies supine. The quantification of&#xD;
      B-lines is performed according to their extent over the lung fields. All the information are&#xD;
      recorded in dedicated forms.&#xD;
&#xD;
      The results are evaluated according to the following criteria. The primary end-point is a&#xD;
      significant reduction of hospitalizations for acute decompensated HF in group A during the&#xD;
      follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life&#xD;
      test (QLT) score and cardiac mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Because at the interim analysis the pre-specified stopping boundary for an overwhelming benefit&#xD;
    had been crossed.&#xD;
  </why_stopped>
  <start_date type="Actual">December 2010</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of hospitalizations for acute decompensated heart failure</measure>
    <time_frame>90 days</time_frame>
    <description>Significant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Natriuretic peptides values</measure>
    <time_frame>90 days</time_frame>
    <description>Significant reduction of natriuretic peptides values in group A during the 90-day follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life test (QLT) score</measure>
    <time_frame>90 days</time_frame>
    <description>Significant reduction of QTL score in group A during the 90-day follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Significant reduction of cardiac mortality rate in group A versus group B.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Chronic Heart Failure</condition>
  <condition>Lung; Congestive</condition>
  <condition>Acute Decompensated Heart Failure</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A includes patients undergoing lung ultrasound and physical examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group B includes patients undergoing physical examination only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung ultrasound</intervention_name>
    <description>Duretic therapy is then optimized according to the presence and severity of B-lines in group A.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) male and female aged between 18 and 90 years (2) signed written informed consent (3)&#xD;
        history of HF for at least six months, (4) left ventricular ejection fraction &lt; 45%, (5)&#xD;
        adequate medical therapy for HF for at least two months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs&#xD;
        or devices within 30 days of clinical assessment, (2) inability to undergo to the planned&#xD;
        follow-up and procedures (3) documented pulmonary infections (4) interstitial lung disease,&#xD;
        class 4 chronic obstructive pulmonary disease according to GOLD guidelines (5) chronic&#xD;
        dialysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Raffaele Hospital</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Agricola Eustachio</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Lung ultrasound</keyword>
  <keyword>B-lines</keyword>
  <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/NCT03262571
org study id: B-LINES
nct id: NCT03262571
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to
      physical examination, leads to a reduction of the admission rate for acute decompensated
      heart failure of patients with chronic heart failure (HF) followed in the outpatients heart
      failure clinic.

      Methods. This is a prospective randomized study. The planned sample size consists of 440
      patients with chronic HF.

      The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed
      written informed consent (3) history of HF for at least six months, (4) left ventricular
      ejection fraction < 45%, (5) adequate medical therapy for HF for at least two months.

      The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or
      treatment with experimental drugs or devices within 30 days of clinical assessment, (2)
      inability to undergo to the planned follow-up and procedures (3) documented pulmonary
      infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease
      according to GOLD classification.

      Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and
      physical examination; and group B, patients undergoing to physical examination only. Patients
      are evaluated at baseline and after three months with medical history, Quality of Life test,
      physical examination, blood sample for hematochemical (creatinine, electrolytes,
      BNP/NTpro-BNP).

      The diuretic therapy is then optimized according to the presence and severity of B-lines in
      group A and physical examination in group B.

      Only patients enrolled in group A undergo to a lung ultrasound examination to assess the
      extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the
      contrast between air-filled structures and water-thickened pulmonary interlobular septa. This
      leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in
      the screen. The ultrasound examination is performed with a handheld echocardiography device.
      The physician carries out a scan of the pulmonary fields, from basal towards mid and apical
      fields, through the midaxillary line while the patient lies supine. The quantification of
      B-lines is performed according to their extent over the lung fields. All the information are
      recorded in dedicated forms.

      The results are evaluated according to the following criteria. The primary end-point is a
      significant reduction of hospitalizations for acute decompensated HF in group A during the
      follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life
      test (QLT) score and cardiac mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of hospitalizations for acute decompensated heart failure
time frame: 90 days
description: Significant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period.
measure: Natriuretic peptides values
time frame: 90 days
description: Significant reduction of natriuretic peptides values in group A during the 90-day follow-up period.
measure: Quality of life test (QLT) score
time frame: 90 days
description: Significant reduction of QTL score in group A during the 90-day follow-up period.
measure: Cardiac mortality
time frame: 90 days
description: Significant reduction of cardiac mortality rate in group A versus group B.
arm group label: Group A
arm group type: Experimental
description: Group A includes patients undergoing lung ultrasound and physical examination.
arm group label: Group B
arm group type: Placebo Comparator
description: Group B includes patients undergoing physical examination only.
intervention type: Diagnostic Test
intervention name: Lung ultrasound
description: Duretic therapy is then optimized according to the presence and severity of B-lines in group A.
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Agricola Eustachio
investigator title: MD
mesh term: Heart Failure
sharing ipd: No