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/NCT06015373</url>
    </required_header>
    <id_info>
      <org_study_id>LHU-2023-001</org_study_id>
      <nct_id>NCT06015373</nct_id>
    </id_info>
    <brief_title>The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension</brief_title>
    <official_title>The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro Hospitalar De São João, E.P.E.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro Hospitalar De São João, E.P.E.</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>
        Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal&#xD;
        hypertension. However, there is still a debate in dosing regimen, specially regarding dose&#xD;
        interval, with a potential lower bioavalability in once daily regimens. The aim of this study&#xD;
        is to assess the acute effects of carvedilol posology in patients with clinically significant&#xD;
        portal hypertension (CSPH), as a surrogate marker of bioavailability.&#xD;
  &#xD;
        In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to&#xD;
        supress the night dose of carvedilol, in order to have a dose interval of approximately 24&#xD;
        hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and&#xD;
        compared with SSM prior or under treatment. Same procedure was applied to liver stiffness&#xD;
        measurement (LSM).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>spleen stiffness measurement (SSM)</measure>
      <time_frame>Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol</time_frame>
      <description>Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>liver stiffness measurement (LSM)</measure>
      <time_frame>Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol</time_frame>
      <description>Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">34</enrollment>
    <condition>Clinically Significant Portal Hypertension</condition>
    <arm_group>
      <arm_group_label>Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this experimental study, 34 patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>supress the night dose of carvedilol</intervention_name>
      <description>already described</description>
      <arm_group_label>Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of&#xD;
               carvedilol)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-responders to non-selective β-blockers (NSBB)&#xD;
  &#xD;
            -  NSBB other than carvedilol&#xD;
  &#xD;
            -  Dosing regimen other than twice daily&#xD;
  &#xD;
            -  No SSM or LSM within 3 months prior to the beginning of the study&#xD;
  &#xD;
            -  Body mass index (BMI) &gt; 30 m/kg2&#xD;
  &#xD;
            -  Contraindications to NSBB use&#xD;
  &#xD;
            -  Portal venous thrombosis&#xD;
  &#xD;
            -  Refusal to participate in the study&#xD;
  &#xD;
            -  Failure to comply to the study regimen&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>77 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centro Hospitalar de Trás os Montes e Alto Douro</name>
        <address>
          <city>Vila Real</city>
          <state>Lordelo</state>
          <zip>5000-508</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centro Hospitalar De São João, E.P.E.</investigator_affiliation>
      <investigator_full_name>Bruno Besteiro</investigator_full_name>
      <investigator_title>MD, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>portal hypertension</keyword>
    <keyword>carvedilol</keyword>
    <keyword>elastography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Portal</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carvedilol</mesh_term>
    </intervention_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 31, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT06015373/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>May 31, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT06015373/SAP_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06015373
  org study id: LHU-2023-001
  nct id: NCT06015373
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal
        hypertension. However, there is still a debate in dosing regimen, specially regarding dose
        interval, with a potential lower bioavalability in once daily regimens. The aim of this study
        is to assess the acute effects of carvedilol posology in patients with clinically significant
        portal hypertension (CSPH), as a surrogate marker of bioavailability.
  
        In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to
        supress the night dose of carvedilol, in order to have a dose interval of approximately 24
        hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and
        compared with SSM prior or under treatment. Same procedure was applied to liver stiffness
        measurement (LSM).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: spleen stiffness measurement (SSM)
  time frame: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
  description: Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
  measure: liver stiffness measurement (LSM)
  time frame: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
  description: Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
  arm group label: Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol
  arm group type: Experimental
  description: In this experimental study, 34 patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).
  intervention type: Drug
  intervention name: supress the night dose of carvedilol
  description: already described
  arm group label: Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 77 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Portugal
  responsible party type: Principal Investigator
  investigator affiliation: Centro Hospitalar De São João, E.P.E.
  investigator full name: Bruno Besteiro
  investigator title: MD, Principal Investigator
  mesh term: Hypertension, Portal
  mesh term: Hypertension
  mesh term: Carvedilol
  provided document: 
  provided document: 