xml: <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/NCT05991089</url>
    </required_header>
    <id_info>
      <org_study_id>DAC-014-TUNCKDH</org_study_id>
      <nct_id>NCT05991089</nct_id>
    </id_info>
    <brief_title>Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients</brief_title>
    <acronym>TUN-CKDH</acronym>
    <official_title>Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dacima Consulting</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tunisian Society for Nephrology, Dialysis and Renal Transplantation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dacima Consulting</source>
    <oversight_info>
      <has_dmc>No</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>
        In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from&#xD;
        28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease,&#xD;
        and its prevalence is quite high in this population. It is both a risk factor for mortality&#xD;
        and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease&#xD;
        becoming an additional public health concern.&#xD;
  &#xD;
        Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a&#xD;
        global public health challenge. A well-conducted treatment makes it possible to reach the&#xD;
        blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event&#xD;
        and to slow the progression of chronic kidney disease.&#xD;
  &#xD;
        In Tunisia, few data exists concerning the prevalence of chronic kidney disease in&#xD;
        hypertensive subjects, thus limiting the development and elaboration of preventive measures.&#xD;
        A national survey will thus be conducted by the &quot;Kidney and Metabolic Diseases&quot; Working Group&#xD;
        under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation.&#xD;
        The main objective is to estimate the prevalence of chronic kidney disease in hypertensive&#xD;
        tunisian patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is national multicentric cross-sectional survey. The study will be carried out for one&#xD;
        month at medical departments and ambulatory clinics of general physicians, family medicine&#xD;
        specialists, endocrinologists, specialists in nutrition and metabolic diseases,&#xD;
        nephrologists, internal medicine physicians, cardiologists, all physicians caring for&#xD;
        non-diabetic hypertensive patients or any healthcare providers in charge of hypertensive&#xD;
        patients.&#xD;
  &#xD;
        A Steering Committee helps investigators to monitor their patient inclusions, performs audit&#xD;
        trails and prepares the statistical analysis plan for the study. Collected data are managed&#xD;
        by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the&#xD;
        FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations&#xD;
        part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and&#xD;
        the ICH standards (International Conference on Harmonisation).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Prevalence of Chronic Kidney Disease</measure>
      <time_frame>At inclusion</time_frame>
      <description>Frequency of hypertensive subjects with chronic kidney disease</description>
    </primary_outcome>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <condition>Hypertension</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All confirmed hypertensive patients at enrollment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed Hypertension&#xD;
  &#xD;
            -  Follow-up at consultation at least for three months before enrollment date&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hypertension emergency&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Kidney transplanted subjects&#xD;
  &#xD;
            -  Dialysis stage&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jannet Labidi, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Military Hospital of Tunis (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amel Harzallah, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Charles Nicolle (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Awatef Azzabi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Sahloul (Sousse, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Badreddine Ben Kaab, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>La Marsa Internal Security Forces Hospital (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ikram Mami, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of La Rabta (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lamia Rais, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of La Rabta (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maissa Hadji Brahim, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Taher Sfar (Mahdia, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mouna Hammouda, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Fattouma Bourguiba (Monastir, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sahar Agrebi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Charles Nicolle (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Seifeddine Azaiez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Private Clinic (Ben Arous, Tunisia)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Soumaya Chargui, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Charles Nicolle (Tunis, Tunisia)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jannet Labidi, MD</last_name>
      <phone>(+216)98902575</phone>
      <email>laabidi.jannet@yahoo.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rabie Razgallah, MD</last_name>
      <phone>(+216) 98343037</phone>
      <email>rabie.razgallah@evidentiq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tunisian Society for Nephrology, Dialysis and Renal Transplantation</name>
        <address>
          <city>Tunis</city>
          <zip>1000</zip>
          <country>Tunisia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Tunisia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991089
  org study id: DAC-014-TUNCKDH
  nct id: NCT05991089
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from
        28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease,
        and its prevalence is quite high in this population. It is both a risk factor for mortality
        and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease
        becoming an additional public health concern.
  
        Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a
        global public health challenge. A well-conducted treatment makes it possible to reach the
        blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event
        and to slow the progression of chronic kidney disease.
  
        In Tunisia, few data exists concerning the prevalence of chronic kidney disease in
        hypertensive subjects, thus limiting the development and elaboration of preventive measures.
        A national survey will thus be conducted by the "Kidney and Metabolic Diseases" Working Group
        under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation.
        The main objective is to estimate the prevalence of chronic kidney disease in hypertensive
        tunisian patients.
  This is national multicentric cross-sectional survey. The study will be carried out for one
        month at medical departments and ambulatory clinics of general physicians, family medicine
        specialists, endocrinologists, specialists in nutrition and metabolic diseases,
        nephrologists, internal medicine physicians, cardiologists, all physicians caring for
        non-diabetic hypertensive patients or any healthcare providers in charge of hypertensive
        patients.
  
        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: Cross-Sectional
  measure: Prevalence of Chronic Kidney Disease
  time frame: At inclusion
  description: Frequency of hypertensive subjects with chronic kidney disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Jannet Labidi, MD
  role: Study Chair
  affiliation: Military Hospital of Tunis (Tunis, Tunisia)
  last name: Amel Harzallah, MD
  role: Principal Investigator
  affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
  last name: Awatef Azzabi, MD
  role: Principal Investigator
  affiliation: University Hospital of Sahloul (Sousse, Tunisia)
  last name: Badreddine Ben Kaab, MD
  role: Principal Investigator
  affiliation: La Marsa Internal Security Forces Hospital (Tunis, Tunisia)
  last name: Ikram Mami, MD
  role: Principal Investigator
  affiliation: University Hospital of La Rabta (Tunis, Tunisia)
  last name: Lamia Rais, MD
  role: Principal Investigator
  affiliation: University Hospital of La Rabta (Tunis, Tunisia)
  last name: Maissa Hadji Brahim, MD
  role: Principal Investigator
  affiliation: University Hospital of Taher Sfar (Mahdia, Tunisia)
  last name: Mouna Hammouda, MD
  role: Principal Investigator
  affiliation: University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
  last name: Sahar Agrebi, MD
  role: Principal Investigator
  affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
  last name: Seifeddine Azaiez, MD
  role: Principal Investigator
  affiliation: Private Clinic (Ben Arous, Tunisia)
  last name: Soumaya Chargui, MD
  role: Principal Investigator
  affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
  last name: Jannet Labidi, MD
  phone: (+216)98902575
  email: laabidi.jannet@yahoo.fr
  last name: Rabie Razgallah, MD
  phone: (+216) 98343037
  email: rabie.razgallah@evidentiq.com
  facility: 
  country: Tunisia
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  sharing ipd: No