<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/NCT03771209</url>
  </required_header>
  <id_info>
    <org_study_id>ABCDE</org_study_id>
    <nct_id>NCT03771209</nct_id>
  </id_info>
  <brief_title>The &quot;ABCDE&quot; Score as a Five-step Vascular Ultrasound Examination in Heart Failure</brief_title>
  <official_title>The &quot;ABCDE&quot; Score as a Five-step Vascular Ultrasound Examination in Heart Failure:a Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Of Perugia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Sacro Cuore Don Calabria di Negrar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliera Universitaria Integrata Verona</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>
      Heart failure (HF) is a clinical syndrome caused by structural and/or functional cardiac&#xD;
      abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures&#xD;
      at rest or during stress. It is the leading cause of hospitalization in Internal Medicine&#xD;
      departments.&#xD;
&#xD;
      This study aims at exploring evidence of the importance of ultrasound in HF both for&#xD;
      hospitalized patients and in the follow up. Ultrasound may be used as a recovery monitoring&#xD;
      instrument at the bedside and also as a global cardiovascular assessment tool for these&#xD;
      patients.&#xD;
&#xD;
      HF represents an exciting opportunity to create an integrative ultrasound approach in&#xD;
      Internal Medicine/Geriatric departments.The Authors plan a five-step ultrasound examination&#xD;
      to evaluate and monitor HF patients during hospitalization and follow-up. They call this&#xD;
      examination: the &quot;ABCDE&quot; score. It includes the evaluations of A, the Ankle-brachial index&#xD;
      (ABI), B, the B-lines, C, the Carotid intima media thickness (CIMT), D, the Diameter of the&#xD;
      abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the&#xD;
      ejection fraction.This score represent an integrative ultrasound approach in Internal&#xD;
      Medicine/Geriatric departments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Heart failure (HF) is a clinical syndrome characterized by typical symptoms and&#xD;
      signs caused by structural and/or functional cardiac abnormalities, resulting in a reduced&#xD;
      cardiac output and/or elevated intra-cardiac pressures at rest or during stress. The&#xD;
      prevalence of HF is approximately 1-2% of the adult population in developed countries, rising&#xD;
      to ≥10% among people &gt;70 years of age and it is the leading cause of hospitalization.&#xD;
&#xD;
      The aim of this study is the creation of a five-step ultrasound examination to evaluate and&#xD;
      monitor HF patients during hospitalization and short follow-up.&#xD;
&#xD;
      The &quot;ABCDE&quot; score includes the evaluations of A, the Ankle-brachial index, ABI, B, the&#xD;
      B-lines, C, the Carotid intima media thickness, CIMT, D, the Diameter of the abdominal aorta&#xD;
      and of the inferior cave vein and E, the echocardiographic assessment of the ejection&#xD;
      fraction.&#xD;
&#xD;
      This score represents an integrative ultrasound approach in the Internal Medicine/Geriatric&#xD;
      departments:&#xD;
&#xD;
      A (ANKLE-BRACHIAL INDEX) Normal (&lt;90): points 0 Mild obstruction (0.71-0.90): points 1&#xD;
      Moderate obstruction (0.41-0.70): points 2 Severe obstruction 0-0.40): points 3 B (B-LINES)&#xD;
      Number of B-lines for each space ≤5: points 0 Number of B-lines for each space ≥ 6 to ≤ 9:&#xD;
      points 1 Number of B-lines for each space ≥ 10 (&quot;Full white screen&quot;): points 3 C (IMT OR&#xD;
      CAROTID PLAQUE) Normal: points 0 Altered IMT (&gt;0.9 mm): points 1 Plaque presence (no&#xD;
      significant stenosis, &lt;70% following NASCET classification): points 2 Plaque presence&#xD;
      (significant stenosis, &gt;70% following NASCET classification): points 3 D (DIAMETER OF AORTA&#xD;
      AND VCI COLLAPSIBILITY INDEX) Aorta Normal (&lt;25 mm): points 0 Normal diameter but with&#xD;
      calcifications: points 1 Ectasia (25-30 mm): points 2 Aneurysm (&gt;30mm): points 3 Cave Vein&#xD;
      Normal collapsibility index (40-75%): points 0 Altered collapsibility index (if &lt;40% or&#xD;
      &gt;75%): points 1 E (EF ACCORDING TO ESC GUIDELINES 2016) HFpEF (LVEF ≥50%): points 0 HFmrEF&#xD;
      (LVEF in the range of 40-49%):points 1 HFrEF (LVEF&lt;40%): points 2&#xD;
&#xD;
      Methods: The study population is composed of a consecutive sample of n' HF patients admitted&#xD;
      from the Emergency to the Internal Medicine (IM)/Geriatric Departments of n' University&#xD;
      Hospitals from Italy or other foreign countries.&#xD;
&#xD;
      HF criteria will be established according to the recent ESC 2016 guidelines. In particular,&#xD;
      patients will be classified in three different classes: with normal left ventricular ejection&#xD;
      fraction (LVEF) ( ≥50%, HF with preserved EF, HFpEF), with reduced LVEF ( &lt;40%, HF with&#xD;
      reduced EF, HfrEF) and with an LVEF in the range of 40-49% (HfmrEF).&#xD;
&#xD;
      Moreover, patients are classified according to New York Heart Association (NYHA) classes at&#xD;
      admission, at discharge and during follow-up.&#xD;
&#xD;
      Exclusion criteria are: concomitant acute coronary syndrome, pneumonia, chronic obstructive&#xD;
      pulmonary disease, lung cancer or metastases, lung fibrosis, previous pneumonectomy or&#xD;
      lobectomy, breast prothesis, obesity, also in order to to avoid the detection of B-lines&#xD;
      other than due to HF.&#xD;
&#xD;
      Patients undergo: A (calculated for each leg at admission), B-lines counting (calculated at&#xD;
      admission, during hospital stay and at discharge with lung ultrasound, approach 72 spaces), C&#xD;
      (at admission), D (at admission for the aorta and at admission, during hospital stay and at&#xD;
      discharge for the inferior cave vein) and E (at admission and discharge).&#xD;
&#xD;
      Venous blood samples are collected from each subject for routine examination on admission:&#xD;
      hemoglobin and white blood cells count, serum creatinine, sodium, potassium, urea, total&#xD;
      cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL)&#xD;
      cholesterol, triglycerides, glucose, C-reactive protein (CRP) (measured with standard&#xD;
      methods).&#xD;
&#xD;
      Moreover, NT-proBNP dosage is obtained on admission and on discharge. Urine output and&#xD;
      diuretic dosage will be carefully reported daily. Arterial blood samples is collected on&#xD;
      admission and on discharge to test the partial pressure of oxygen (PaO2) as indicator of HF&#xD;
      severity (on admission) and recovery (on discharge).&#xD;
&#xD;
      An electrocardiogram recording and X-chest ray examination are obtained on admission.&#xD;
&#xD;
      MEDICAL STAFF INVOLVED IN THE ULTRASOUND EXAMINATIONS A is performed by the IM/Geriatric&#xD;
      specialists or certification board attending students.&#xD;
&#xD;
      B,C and D examinations are performed by Medical Doctors (Radiologists or IM/Geriatric&#xD;
      specialists certified by the Società Italiana di Ultrasonologia in Medicina e Biologia&#xD;
      (SIUMB).&#xD;
&#xD;
      Trans-thoracic echocardiography with estimation of E is performed by Cardiologists or IM&#xD;
      specialists certified by the Società Italiana di Ecografia Cardiovascolare, SIEC.&#xD;
&#xD;
        -  ENDPOINTS:&#xD;
&#xD;
           1) RELATED TO THE BEDSIDE EVALUATION OF HF RECOVERY:&#xD;
&#xD;
        -  test if B,D (for cave vein) and E assessment can precisely guide and tailoring the&#xD;
           therapy (diuretics) during hospitalization and recovery from HF;&#xD;
&#xD;
        -  test if B,D (for cave vein) and E assessment can speed up the discharge time (if&#xD;
           compared to patients without ultrasound assessment);&#xD;
&#xD;
        -  improve the use of bedside ultrasound in IM and Geriatric department. 2) RELATED TO THE&#xD;
           GLOBAL CARDIOVASCULAR ASSESSMENT OF THE HF PATIENT:&#xD;
&#xD;
        -  test if A, C and D (for aorta) assessment can better classify the global cardiovascular&#xD;
           risk for the HF patient.&#xD;
&#xD;
      The severity of the score will be related with:&#xD;
&#xD;
        -  number of hospitalization days&#xD;
&#xD;
        -  number of &quot;events&quot; during follow up (for definition of &quot;events&quot;, see follow up section).&#xD;
&#xD;
      FOLLOW-UP Follow-up is performed by contacting patients or their caregivers over the phone 30&#xD;
      and 90 days after the date of discharge. All the successive re-admissions for HF or deaths&#xD;
      from any cause are considered as &quot;events&quot;.&#xD;
&#xD;
      A potential correlation between the severity of each parameter considered in the &quot;ABCDE&quot;&#xD;
      score with the &quot;events&quot; after discharge is tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Anticipated">April 26, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 26, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>discharge time shortening</measure>
    <time_frame>1 month</time_frame>
    <description>B-lines number in relation to the discharge time (number of days of hospitalization)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABCDE and events</measure>
    <time_frame>3 months</time_frame>
    <description>association between number of altered ultrasound parameters and number of &quot;events&quot; (death from any cause or re-admission for HF) in a follow up period (30 and 90 days from discharge)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>B lines and diuretics shifts</measure>
    <time_frame>1 month</time_frame>
    <description>association between B lines number and the number of diuretics shifts during hospitalization and recovery from HF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B lines and PaO2</measure>
    <time_frame>1 month</time_frame>
    <description>association between B lines number and calculated ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) at admission and discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B lines and natriuretic peptide</measure>
    <time_frame>1 month</time_frame>
    <description>the association of B lines number and natriuretic peptide blood levels (ng/mL)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Heart Failure</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>ultrasound assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The aim of this study is the creation of a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and short follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasound examination</intervention_name>
    <description>ultrasound assessment</description>
    <arm_group_label>ultrasound assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HF patients admitted from the Emergency to the Internal Medicine (IM)/Geriatric&#xD;
             Departments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant acute coronary syndrome&#xD;
&#xD;
          -  pneumonia&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  lung cancer or metastases&#xD;
&#xD;
          -  lung fibrosis&#xD;
&#xD;
          -  previous pneumonectomy or lobectomy&#xD;
&#xD;
          -  breast prothesis&#xD;
&#xD;
          -  obesity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHIARA MOZZINI, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universita di Verona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DOMENICO GIRELLI, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universita di Verona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MAURIZIO SORESI, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Palermo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CHIARA MOZZINI, MD,PhD</last_name>
    <phone>+390458124262</phone>
    <email>chiara.mozzini@univr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Verona</name>
      <address>
        <city>Verona</city>
        <zip>37136</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHIARA MOZZINI, MD,PhD</last_name>
      <phone>+390458124262</phone>
      <email>chiara.mozzini@univr.it</email>
    </contact>
    <investigator>
      <last_name>chiara mozzini, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>maurizio soresi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>domenico girelli, MD,PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>marco di dio perna, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>stefano ministrini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>francesco fantin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>luciano cominacini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Mozzini C, Cominacini L, Casadei A, Schiavone C, Soresi M. Ultrasonography in Heart Failure: A Story that Matters. Curr Probl Cardiol. 2019 Apr;44(4):116-136. doi: 10.1016/j.cpcardiol.2018.05.003. Epub 2018 Jun 21.</citation>
    <PMID>30172551</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Universitaria Integrata Verona</investigator_affiliation>
    <investigator_full_name>Chiara Mozzini</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ultrasound assessment</keyword>
  <keyword>ankle brachial index</keyword>
  <keyword>lung ultrasound</keyword>
  <keyword>carotid intima media thickness</keyword>
  <keyword>vascular ultrasound (abdominal aorta and cave vein)</keyword>
  <keyword>echocardiographic ejection fraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03771209
org study id: ABCDE
nct id: NCT03771209
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Heart failure (HF) is a clinical syndrome caused by structural and/or functional cardiac
      abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures
      at rest or during stress. It is the leading cause of hospitalization in Internal Medicine
      departments.

      This study aims at exploring evidence of the importance of ultrasound in HF both for
      hospitalized patients and in the follow up. Ultrasound may be used as a recovery monitoring
      instrument at the bedside and also as a global cardiovascular assessment tool for these
      patients.

      HF represents an exciting opportunity to create an integrative ultrasound approach in
      Internal Medicine/Geriatric departments.The Authors plan a five-step ultrasound examination
      to evaluate and monitor HF patients during hospitalization and follow-up. They call this
      examination: the "ABCDE" score. It includes the evaluations of A, the Ankle-brachial index
      (ABI), B, the B-lines, C, the Carotid intima media thickness (CIMT), D, the Diameter of the
      abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the
      ejection fraction.This score represent an integrative ultrasound approach in Internal
      Medicine/Geriatric departments.
Background: Heart failure (HF) is a clinical syndrome characterized by typical symptoms and
      signs caused by structural and/or functional cardiac abnormalities, resulting in a reduced
      cardiac output and/or elevated intra-cardiac pressures at rest or during stress. The
      prevalence of HF is approximately 1-2% of the adult population in developed countries, rising
      to ≥10% among people >70 years of age and it is the leading cause of hospitalization.

      The aim of this study is the creation of a five-step ultrasound examination to evaluate and
      monitor HF patients during hospitalization and short follow-up.

      The "ABCDE" score includes the evaluations of A, the Ankle-brachial index, ABI, B, the
      B-lines, C, the Carotid intima media thickness, CIMT, D, the Diameter of the abdominal aorta
      and of the inferior cave vein and E, the echocardiographic assessment of the ejection
      fraction.

      This score represents an integrative ultrasound approach in the Internal Medicine/Geriatric
      departments:

      A (ANKLE-BRACHIAL INDEX) Normal (<90): points 0 Mild obstruction (0.71-0.90): points 1
      Moderate obstruction (0.41-0.70): points 2 Severe obstruction 0-0.40): points 3 B (B-LINES)
      Number of B-lines for each space ≤5: points 0 Number of B-lines for each space ≥ 6 to ≤ 9:
      points 1 Number of B-lines for each space ≥ 10 ("Full white screen"): points 3 C (IMT OR
      CAROTID PLAQUE) Normal: points 0 Altered IMT (>0.9 mm): points 1 Plaque presence (no
      significant stenosis, <70% following NASCET classification): points 2 Plaque presence
      (significant stenosis, >70% following NASCET classification): points 3 D (DIAMETER OF AORTA
      AND VCI COLLAPSIBILITY INDEX) Aorta Normal (<25 mm): points 0 Normal diameter but with
      calcifications: points 1 Ectasia (25-30 mm): points 2 Aneurysm (>30mm): points 3 Cave Vein
      Normal collapsibility index (40-75%): points 0 Altered collapsibility index (if <40% or
      >75%): points 1 E (EF ACCORDING TO ESC GUIDELINES 2016) HFpEF (LVEF ≥50%): points 0 HFmrEF
      (LVEF in the range of 40-49%):points 1 HFrEF (LVEF<40%): points 2

      Methods: The study population is composed of a consecutive sample of n' HF patients admitted
      from the Emergency to the Internal Medicine (IM)/Geriatric Departments of n' University
      Hospitals from Italy or other foreign countries.

      HF criteria will be established according to the recent ESC 2016 guidelines. In particular,
      patients will be classified in three different classes: with normal left ventricular ejection
      fraction (LVEF) ( ≥50%, HF with preserved EF, HFpEF), with reduced LVEF ( <40%, HF with
      reduced EF, HfrEF) and with an LVEF in the range of 40-49% (HfmrEF).

      Moreover, patients are classified according to New York Heart Association (NYHA) classes at
      admission, at discharge and during follow-up.

      Exclusion criteria are: concomitant acute coronary syndrome, pneumonia, chronic obstructive
      pulmonary disease, lung cancer or metastases, lung fibrosis, previous pneumonectomy or
      lobectomy, breast prothesis, obesity, also in order to to avoid the detection of B-lines
      other than due to HF.

      Patients undergo: A (calculated for each leg at admission), B-lines counting (calculated at
      admission, during hospital stay and at discharge with lung ultrasound, approach 72 spaces), C
      (at admission), D (at admission for the aorta and at admission, during hospital stay and at
      discharge for the inferior cave vein) and E (at admission and discharge).

      Venous blood samples are collected from each subject for routine examination on admission:
      hemoglobin and white blood cells count, serum creatinine, sodium, potassium, urea, total
      cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL)
      cholesterol, triglycerides, glucose, C-reactive protein (CRP) (measured with standard
      methods).

      Moreover, NT-proBNP dosage is obtained on admission and on discharge. Urine output and
      diuretic dosage will be carefully reported daily. Arterial blood samples is collected on
      admission and on discharge to test the partial pressure of oxygen (PaO2) as indicator of HF
      severity (on admission) and recovery (on discharge).

      An electrocardiogram recording and X-chest ray examination are obtained on admission.

      MEDICAL STAFF INVOLVED IN THE ULTRASOUND EXAMINATIONS A is performed by the IM/Geriatric
      specialists or certification board attending students.

      B,C and D examinations are performed by Medical Doctors (Radiologists or IM/Geriatric
      specialists certified by the Società Italiana di Ultrasonologia in Medicina e Biologia
      (SIUMB).

      Trans-thoracic echocardiography with estimation of E is performed by Cardiologists or IM
      specialists certified by the Società Italiana di Ecografia Cardiovascolare, SIEC.

        -  ENDPOINTS:

           1) RELATED TO THE BEDSIDE EVALUATION OF HF RECOVERY:

        -  test if B,D (for cave vein) and E assessment can precisely guide and tailoring the
           therapy (diuretics) during hospitalization and recovery from HF;

        -  test if B,D (for cave vein) and E assessment can speed up the discharge time (if
           compared to patients without ultrasound assessment);

        -  improve the use of bedside ultrasound in IM and Geriatric department. 2) RELATED TO THE
           GLOBAL CARDIOVASCULAR ASSESSMENT OF THE HF PATIENT:

        -  test if A, C and D (for aorta) assessment can better classify the global cardiovascular
           risk for the HF patient.

      The severity of the score will be related with:

        -  number of hospitalization days

        -  number of "events" during follow up (for definition of "events", see follow up section).

      FOLLOW-UP Follow-up is performed by contacting patients or their caregivers over the phone 30
      and 90 days after the date of discharge. All the successive re-admissions for HF or deaths
      from any cause are considered as "events".

      A potential correlation between the severity of each parameter considered in the "ABCDE"
      score with the "events" after discharge is tested.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: discharge time shortening
time frame: 1 month
description: B-lines number in relation to the discharge time (number of days of hospitalization)
measure: ABCDE and events
time frame: 3 months
description: association between number of altered ultrasound parameters and number of "events" (death from any cause or re-admission for HF) in a follow up period (30 and 90 days from discharge)
measure: B lines and diuretics shifts
time frame: 1 month
description: association between B lines number and the number of diuretics shifts during hospitalization and recovery from HF
measure: B lines and PaO2
time frame: 1 month
description: association between B lines number and calculated ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) at admission and discharge
measure: B lines and natriuretic peptide
time frame: 1 month
description: the association of B lines number and natriuretic peptide blood levels (ng/mL)
arm group label: ultrasound assessment
arm group type: Experimental
description: The aim of this study is the creation of a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and short follow-up.
intervention type: Diagnostic Test
intervention name: ultrasound examination
description: ultrasound assessment
arm group label: ultrasound assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CHIARA MOZZINI, MD,PhD
role: Principal Investigator
affiliation: Universita di Verona
last name: DOMENICO GIRELLI, MD,PhD
role: Study Chair
affiliation: Universita di Verona
last name: MAURIZIO SORESI, MD,PhD
role: Study Chair
affiliation: University of Palermo
last name: CHIARA MOZZINI, MD,PhD
phone: +390458124262
email: chiara.mozzini@univr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
citation: Mozzini C, Cominacini L, Casadei A, Schiavone C, Soresi M. Ultrasonography in Heart Failure: A Story that Matters. Curr Probl Cardiol. 2019 Apr;44(4):116-136. doi: 10.1016/j.cpcardiol.2018.05.003. Epub 2018 Jun 21.
PMID: 30172551
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Universitaria Integrata Verona
investigator full name: Chiara Mozzini
investigator title: Principal Investigator
mesh term: Heart Failure
mesh term: Atherosclerosis
sharing ipd: Undecided