<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/NCT03262675</url>
  </required_header>
  <id_info>
    <org_study_id>DAC-002-NATUREHF</org_study_id>
    <nct_id>NCT03262675</nct_id>
  </id_info>
  <brief_title>NAtional TUnisian REgistry of Heart Failure</brief_title>
  <acronym>NATURE-HF</acronym>
  <official_title>National Tunisian Registry of Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dacima Consulting</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société Tunisienne de Cardiologie &amp; de Chirurgie Cardio-Vasculaire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dacima Consulting</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>
      NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed&#xD;
      with 100 tunisian cardiologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NATURE-HF is a national clinical non-interventional registry of heart failure, carried&#xD;
      out in Tunisia at cardiology departments in hospitals and in liberal cardiology&#xD;
      consultations. 100 cardiologists participate in the enrollment of the eligible patients as&#xD;
      investigators. A Committee of Experts validates the protocol methodology and supervises the&#xD;
      data-management. A Steering Committee helps investigators to monitor their patient&#xD;
      inclusions, performs audit trails and prepares the statistical analysis plan for the study.&#xD;
&#xD;
      Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture&#xD;
      platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug&#xD;
      Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health&#xD;
      Insurance Portability and Accountability Act), and the ICH standards (International&#xD;
      Conference on Harmonisation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">January 12, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2017</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>Cardiovascular death</measure>
    <time_frame>Time-To-Event measure up to 12 months from baseline</time_frame>
    <description>Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Failure Readmission</measure>
    <time_frame>At 1, 3 and 12 months from patient enrollment</time_frame>
    <description>Incidence of heart failure readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Death</measure>
    <time_frame>Time-To-Event measure up to 12 months from baseline</time_frame>
    <description>Incidence of death of all causes (cardiovascular death and non-cardiovascular death)</description>
  </secondary_outcome>
  <enrollment type="Actual">2040</enrollment>
  <condition>Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with chronic heart failure&#xD;
&#xD;
          -  Patient with acute heart failure (new onset or not)&#xD;
&#xD;
          -  The diagnosis of heart failure is at the discretion of the investigator&#xD;
&#xD;
          -  Informed and signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt;12 months for extra cardiac disease&#xD;
&#xD;
          -  Isolated Right Heart Failure&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Renal failure with creatinine clearance &lt; 15 ml / min&#xD;
&#xD;
          -  Hemodialysis patients&#xD;
&#xD;
          -  Cardiac surgery planned within 3 months&#xD;
&#xD;
          -  Congenital heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faouzi Addad, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Société Tunisienne de Cardiologie &amp; de Chirurgie Cardio-Vasculaire</name>
      <address>
        <city>Tunis</city>
        <state>Tunisie</state>
        <zip>1000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 22, 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>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Acute Heart Failure</keyword>
  <keyword>Chronic Heat Failure</keyword>
  <keyword>Cardiovascular diseases</keyword>
  <keyword>Heart diseases</keyword>
  <keyword>Registry</keyword>
  <keyword>Tunisia</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>Yes</sharing_ipd>
    <ipd_description>Clinical Study Report</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Already available</ipd_time_frame>
    <ipd_access_criteria>Free access</ipd_access_criteria>
    <ipd_url>http://www.stcccv-tunisie.com/files/RegistreNatureHF_SFC2019.pdf</ipd_url>
  </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/NCT03262675
org study id: DAC-002-NATUREHF
nct id: NCT03262675
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed
      with 100 tunisian cardiologists.
The NATURE-HF is a national clinical non-interventional registry of heart failure, carried
      out in Tunisia at cardiology departments in hospitals and in liberal cardiology
      consultations. 100 cardiologists participate in the enrollment of the eligible patients as
      investigators. A Committee of Experts validates the protocol methodology and supervises the
      data-management. A Steering Committee helps investigators to monitor their patient
      inclusions, performs audit trails and prepares the statistical analysis plan for the study.

      Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture
      platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug
      Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health
      Insurance Portability and Accountability Act), and the ICH standards (International
      Conference on Harmonisation).
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular death
time frame: Time-To-Event measure up to 12 months from baseline
description: Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke
measure: Heart Failure Readmission
time frame: At 1, 3 and 12 months from patient enrollment
description: Incidence of heart failure readmissions
measure: Global Death
time frame: Time-To-Event measure up to 12 months from baseline
description: Incidence of death of all causes (cardiovascular death and non-cardiovascular death)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Faouzi Addad, Professor
role: Study Chair
affiliation: Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
facility: 
country: Tunisia
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Yes
ipd description: Clinical Study Report
ipd info type: Clinical Study Report (CSR)
ipd time frame: Already available
ipd access criteria: Free access
ipd url: http://www.stcccv-tunisie.com/files/RegistreNatureHF_SFC2019.pdf