<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/NCT03806972</url>
  </required_header>
  <id_info>
    <org_study_id>CRF</org_study_id>
    <nct_id>NCT03806972</nct_id>
  </id_info>
  <brief_title>Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure</brief_title>
  <acronym>CRF</acronym>
  <official_title>Short and Long Term Prognosis of Patients Admitted to the Emergency Department With Acute Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</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 the leading cause of hospitalization ,rehospitalization and mortality&#xD;
      for adults over 65 years of age.&#xD;
&#xD;
      This study aimed to assess mortality, and hospitalization rates at 30 days and one year after&#xD;
      dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared&#xD;
      to HF with preserved ejection fraction (HFpEF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2009</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Death or readmission rates</measure>
    <time_frame>within 365 days after hospital discharge</time_frame>
    <description>A composite outcome of Death or readmission within 365 days of hospital discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death or readmission rates</measure>
    <time_frame>within 30 days after hospital discharge</time_frame>
    <description>A composite outcome of Death or readmission within 30 days of hospital discharge</description>
  </secondary_outcome>
  <enrollment type="Actual">1800</enrollment>
  <condition>Acute Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study included all patients ,with either reduced ejection fraction (HFrEF) defined as&#xD;
        LVEF &lt;45% or preserved ejection fraction (HFpEF) defined as LVEF ≥45% ,admitted to the ED&#xD;
        of Monastir between 2009-2020 with a principal discharge diagnosis code for HF. The&#xD;
        diagnosis of HF categories should rely on the recent transthoracic echocardiographic&#xD;
        findings and clinical judgement according to the guidelines.Collected data include clinical&#xD;
        features biological markers (BNP or NTpro BNP) and echocardiography findings. The diagnosis&#xD;
        of HF categories should rely on the recent transthoracic echocardiographic findings and&#xD;
        clinical judgement according to the guidelines. A follow-up period of at least 1 year was&#xD;
        required to notice all cause mortality and preferably HF-specific rehospitalization .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted to the ED of Monastir with a principal discharge diagnosis code for&#xD;
             HF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding women. Alteration of consciousness GCS &lt; 15 Critically ill&#xD;
             patients needing immediate mechanical hemodynamic of ventilatory support.&#xD;
&#xD;
        Inability to follow instructions or comply with follow-up procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nouira Semir, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>university Hospital of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Departement</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <reference>
    <citation>Castello LM, Molinari L, Renghi A, Peruzzi E, Capponi A, Avanzi GC, Pirisi M. Acute decompensated heart failure in the emergency department: Identification of early predictors of outcome. Medicine (Baltimore). 2017 Jul;96(27):e7401. doi: 10.1097/MD.0000000000007401.</citation>
    <PMID>28682895</PMID>
  </reference>
  <reference>
    <citation>Searle J, Frick J, Mockel M. Acute heart failure facts and numbers: acute heart failure populations. ESC Heart Fail. 2016 Jun;3(2):65-70. doi: 10.1002/ehf2.12092. Epub 2016 Apr 25.</citation>
    <PMID>27818780</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>acute heart failure prognosis</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/NCT03806972
org study id: CRF
nct id: NCT03806972
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality
      for adults over 65 years of age.

      This study aimed to assess mortality, and hospitalization rates at 30 days and one year after
      dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared
      to HF with preserved ejection fraction (HFpEF).
observational model: Cohort
time perspective: Prospective
measure: Death or readmission rates
time frame: within 365 days after hospital discharge
description: A composite outcome of Death or readmission within 365 days of hospital discharge
measure: Death or readmission rates
time frame: within 30 days after hospital discharge
description: A composite outcome of Death or readmission within 30 days of hospital discharge
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nouira Semir, Professor
role: Principal Investigator
affiliation: university Hospital of Monastir
facility: 
country: Tunisia
citation: Castello LM, Molinari L, Renghi A, Peruzzi E, Capponi A, Avanzi GC, Pirisi M. Acute decompensated heart failure in the emergency department: Identification of early predictors of outcome. Medicine (Baltimore). 2017 Jul;96(27):e7401. doi: 10.1097/MD.0000000000007401.
PMID: 28682895
citation: Searle J, Frick J, Mockel M. Acute heart failure facts and numbers: acute heart failure populations. ESC Heart Fail. 2016 Jun;3(2):65-70. doi: 10.1002/ehf2.12092. Epub 2016 Apr 25.
PMID: 27818780
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: professor
mesh term: Heart Failure
sharing ipd: No