<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/NCT02211365</url>
  </required_header>
  <id_info>
    <org_study_id>16/14</org_study_id>
    <nct_id>NCT02211365</nct_id>
  </id_info>
  <brief_title>Registro Campania Salute Network on Hypertension</brief_title>
  <acronym>RCSN</acronym>
  <official_title>Registro Campania Salute Network for the Treatment of Hypertension and Correlated Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the&#xD;
      management of essential hypertension by integrating the activity of general practitioners&#xD;
      (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously&#xD;
      allocated in the regional area, and the Hypertension Clinic of the Federico II University in&#xD;
      Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store&#xD;
      clinical data detected at each visit between the peripheral units and the co-ordinating&#xD;
      centre and to support scientific analysis of the dataset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be followed over a period of twenty years and all clinical data will be&#xD;
      recorded in order to investigate the role of hypertension and correlated disease on this&#xD;
      patient population&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Anticipated">April 2030</completion_date>
  <primary_completion_date type="Actual">March 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>10 Years</target_duration>
  <primary_outcome>
    <measure>MACCE</measure>
    <time_frame>every year up to 20 years</time_frame>
    <description>Major adverse cardiac and cerebrovascular events</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Hypertension; Heart Disease, Hypertensive</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Hypertension&#xD;
&#xD;
          -  18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refused to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno Trimarco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bruno Trimarco, MD</last_name>
    <phone>+390817462250</phone>
    <email>trimarco@unina.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>eugenio stabile, MD</last_name>
    <phone>+393316776019</phone>
    <email>eugeniostabile@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department od advanced biomedical sciences, Università degli studi di Napoli Federico II, Via sergio Pansini 5</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Izzo, MD</last_name>
      <phone>+390817462211</phone>
      <email>rafizzo@unina.it</email>
    </contact>
    <contact_backup>
      <last_name>eugenio Stabile, MD</last_name>
      <phone>+393316776019</phone>
      <email>eugeniostabile@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bruno Trimarco, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>April 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Bruno Trimarco</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>CVD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02211365
org study id: 16/14
nct id: NCT02211365
lead sponsor: 
has dmc: Yes
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the
      management of essential hypertension by integrating the activity of general practitioners
      (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously
      allocated in the regional area, and the Hypertension Clinic of the Federico II University in
      Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store
      clinical data detected at each visit between the peripheral units and the co-ordinating
      centre and to support scientific analysis of the dataset.
The patients will be followed over a period of twenty years and all clinical data will be
      recorded in order to investigate the role of hypertension and correlated disease on this
      patient population
observational model: Cohort
time perspective: Prospective
measure: MACCE
time frame: every year up to 20 years
description: Major adverse cardiac and cerebrovascular events
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bruno Trimarco, MD
role: Principal Investigator
affiliation: Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II
last name: Bruno Trimarco, MD
phone: +390817462250
email: trimarco@unina.it
last name: eugenio stabile, MD
phone: +393316776019
email: eugeniostabile@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Bruno Trimarco
investigator title: Professor
mesh term: Hypertension
mesh term: Heart Diseases