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/NCT05973604</url>
    </required_header>
    <id_info>
      <org_study_id>4418/26/01/2021</org_study_id>
      <nct_id>NCT05973604</nct_id>
    </id_info>
    <brief_title>Prevalence of Primary Aldosteronism in Atrial Fibrillation</brief_title>
    <acronym>ERETRIA</acronym>
    <official_title>Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aristotle University Of Thessaloniki</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aristotle University Of Thessaloniki</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>
        This is an observational prospective cross-sectional study, investigating the prevalence of&#xD;
        primary aldosteronism in patients with atrial fibrillation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of primary aldosteronism in patients with atrial fibrillation</measure>
      <time_frame>Baseline</time_frame>
      <description>Percentage of patients with positive screening and confirmatory test for primary aldosteronism</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation</measure>
      <time_frame>Baseline</time_frame>
      <description>Pulse wave velocity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.</measure>
      <time_frame>Baseline</time_frame>
      <description>Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography</description>
    </secondary_outcome>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Primary Aldosteronism</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Screening and Confirmatory diagnostic test for primary aldosteronism</intervention_name>
      <description>Screening for primary aldosteronism will be performed with measurement of aldosterone-to-renin ratio after 2 hours of bed rest. Renin measurement will be performed by estimating plasma renin activity. The screening test will be considered positive when the ratio is &gt;30, accompanied by elevated aldosterone values (&gt;15 ng/ml). Patients with a positive result will undergo further confirmatory testing with intravenous sodium test (administration 2 liters of normal saline N/S 0.9%, over a period of 4 hours, while the patient is supine. Considered positive if aldosterone levels are &gt;5mg/dl at the end of the test). Alternative confirmatory methods are captopril test (Administration of 50 mg of captopril. Considered positive when aldosterone levels are &gt;8.5 mg/dl 2 hours after the intake) or hydrocortisone test (Administration of 0.1mg of hydrocortisone 4 times a day for a period of 4 days. Considered positive if elevated aldosterone levels (&gt;6ng/dl) are found at the end of the test).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with atrial fibrillation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at&#xD;
               least 30 seconds (either paroxysmal or persistent or permanent).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of primary aldosteronism&#xD;
  &#xD;
            -  Diagnosis of heart failure, treated with mineralocorticoid receptor antagonists&#xD;
  &#xD;
            -  Inability to be subjected to any confirmatory tests for primary aldosteronism&#xD;
  &#xD;
            -  Acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular&#xD;
               event) within last 6 months&#xD;
  &#xD;
            -  Renal replacement therapy&#xD;
  &#xD;
            -  Incompetence of unwillingness to provide written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maria Toumpourleka, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Vassilios P Vassilikos, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Michael Doumas, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Christodoulos E Papadoupoulos</last_name>
      <role>Study Chair</role>
      <affiliation>Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Toumpourleka, MSc</last_name>
      <phone>00302310892343</phone>
      <email>m.toumpourleka@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vassilios P Vassilikos, PhD</last_name>
      <phone>00302310892343</phone>
      <email>vvassil@auth.gr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ippokratio General Hospital</name>
        <address>
          <city>Thessaloniki</city>
          <zip>54642</zip>
          <country>Greece</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Toumpourleka, MSc</last_name>
        <phone>00302310892343</phone>
        <email>m.toumpourleka@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Maria Toumpourleka, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vassilios P Vassilikos, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Michael Doumas, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christodoulos E Papadopoulos, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
      <investigator_full_name>Maria Toumpourleka</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Atrial Fibrillation</keyword>
    <keyword>Primary Aldosteronism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Hyperaldosteronism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05973604
  org study id: 4418/26/01/2021
  nct id: NCT05973604
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational prospective cross-sectional study, investigating the prevalence of
        primary aldosteronism in patients with atrial fibrillation.
  observational model: Case-Only
  time perspective: Prospective
  measure: Prevalence of primary aldosteronism in patients with atrial fibrillation
  time frame: Baseline
  description: Percentage of patients with positive screening and confirmatory test for primary aldosteronism
  measure: Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation
  time frame: Baseline
  description: Pulse wave velocity
  measure: Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.
  time frame: Baseline
  description: Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography
  intervention type: Diagnostic Test
  intervention name: Screening and Confirmatory diagnostic test for primary aldosteronism
  description: Screening for primary aldosteronism will be performed with measurement of aldosterone-to-renin ratio after 2 hours of bed rest. Renin measurement will be performed by estimating plasma renin activity. The screening test will be considered positive when the ratio is >30, accompanied by elevated aldosterone values (>15 ng/ml). Patients with a positive result will undergo further confirmatory testing with intravenous sodium test (administration 2 liters of normal saline N/S 0.9%, over a period of 4 hours, while the patient is supine. Considered positive if aldosterone levels are >5mg/dl at the end of the test). Alternative confirmatory methods are captopril test (Administration of 50 mg of captopril. Considered positive when aldosterone levels are >8.5 mg/dl 2 hours after the intake) or hydrocortisone test (Administration of 0.1mg of hydrocortisone 4 times a day for a period of 4 days. Considered positive if elevated aldosterone levels (>6ng/dl) are found at the end of the test).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Maria Toumpourleka, MSc
  role: Principal Investigator
  affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
  last name: Vassilios P Vassilikos, PhD
  role: Study Director
  affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
  last name: Michael Doumas, PhD
  role: Study Director
  affiliation: Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
  last name: Christodoulos E Papadoupoulos
  role: Study Chair
  affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
  last name: Maria Toumpourleka, MSc
  phone: 00302310892343
  email: m.toumpourleka@gmail.com
  last name: Vassilios P Vassilikos, PhD
  phone: 00302310892343
  email: vvassil@auth.gr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Greece
  responsible party type: Principal Investigator
  investigator affiliation: Aristotle University Of Thessaloniki
  investigator full name: Maria Toumpourleka
  investigator title: Principal Investigator
  mesh term: Atrial Fibrillation
  mesh term: Hyperaldosteronism
  sharing ipd: Undecided