<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/NCT03291145</url>
  </required_header>
  <id_info>
    <org_study_id>260910000001</org_study_id>
    <nct_id>NCT03291145</nct_id>
  </id_info>
  <brief_title>Exploring Mechanisms and Morphology of QT Interval Prolongation</brief_title>
  <acronym>TriQarr</acronym>
  <official_title>Exploring Mechanisms and Morphology of QT Interval Prolongation - An Inheritable as Well as an Inducible Phenomenon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev and Gentofte Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev and Gentofte Hospital</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>
      The projects will try and optimise the risk stratification for patients with Long QT syndrome&#xD;
      by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics&#xD;
      and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation.&#xD;
      Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics&#xD;
      tested by &quot;Brisk Standing&quot;.&#xD;
&#xD;
      First, patients are tested with known arrhythmic triggers and they are then administered&#xD;
      thier normal dose of beta blockers. Hereafter, &quot;Brisk Standing&quot; test is performed and the&#xD;
      patients are on Spironolactone for seven days. After seven days treatment the &quot;Brisk&#xD;
      Standing&quot; is repeated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the projects is to try and optimise the risk stratification for patients with Long&#xD;
      QT syndrome by investigating how the exposure of physical and acoustic stress will affect the&#xD;
      QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic&#xD;
      QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on&#xD;
      the QT-dynamics tested by &quot;Brisk Standing&quot;.&#xD;
&#xD;
      First, patients are tested with known arrhythmic triggers and they are then administered&#xD;
      thier normal dose of beta blockers. Hereafter, &quot;Brisk Standing&quot; test is performed and the&#xD;
      patients are on Spironolactone for seven days. After seven days treatment the &quot;Brisk&#xD;
      Standing&quot; is repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QTc</measure>
    <time_frame>7 days</time_frame>
    <description>Corrected QT</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Long Qt Syndrome 1-2</condition>
  <condition>Sudden Cardiac Death</condition>
  <arm_group>
    <arm_group_label>Beta Blockers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With and without Beta Blockers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spironolactone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With and without Spironolactone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beta Blockers</intervention_name>
    <description>With and without Beta Blockers</description>
    <arm_group_label>Beta Blockers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spironolactone</intervention_name>
    <description>Brisk Standing before and after seven days treatment with Spironolactone</description>
    <arm_group_label>Spironolactone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified Long QT syndrome mutation, subtype 1 or 2.&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrioventricular block,&#xD;
&#xD;
          -  Left bundle branch block,&#xD;
&#xD;
          -  Left ventricular hypertrophy,&#xD;
&#xD;
          -  Pace rhythm,&#xD;
&#xD;
          -  ST-deviations &gt;1 mm),&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;50 % and significant valvulopathy,&#xD;
&#xD;
          -  Unstable psychiatric disease&#xD;
&#xD;
          -  Unstable cardiovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herlev-Gentofte Hospital</name>
      <address>
        <city>Herlev</city>
        <state>Copenhagen</state>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev and Gentofte Hospital</investigator_affiliation>
    <investigator_full_name>Peter Marstrand</investigator_full_name>
    <investigator_title>Medical Doctor, Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Long QT Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Long QT Syndrome</mesh_term>
    <mesh_term>Romano-Ward Syndrome</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spironolactone</mesh_term>
    <mesh_term>Adrenergic beta-Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03291145
org study id: 260910000001
nct id: NCT03291145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The projects will try and optimise the risk stratification for patients with Long QT syndrome
      by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics
      and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation.
      Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics
      tested by "Brisk Standing".

      First, patients are tested with known arrhythmic triggers and they are then administered
      thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the
      patients are on Spironolactone for seven days. After seven days treatment the "Brisk
      Standing" is repeated.
The aim of the projects is to try and optimise the risk stratification for patients with Long
      QT syndrome by investigating how the exposure of physical and acoustic stress will affect the
      QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic
      QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on
      the QT-dynamics tested by "Brisk Standing".

      First, patients are tested with known arrhythmic triggers and they are then administered
      thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the
      patients are on Spironolactone for seven days. After seven days treatment the "Brisk
      Standing" is repeated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: QTc
time frame: 7 days
description: Corrected QT
arm group label: Beta Blockers
arm group type: Experimental
description: With and without Beta Blockers
arm group label: Spironolactone
arm group type: Experimental
description: With and without Spironolactone
intervention type: Drug
intervention name: Beta Blockers
description: With and without Beta Blockers
arm group label: Beta Blockers
intervention type: Drug
intervention name: Spironolactone
description: Brisk Standing before and after seven days treatment with Spironolactone
arm group label: Spironolactone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev and Gentofte Hospital
investigator full name: Peter Marstrand
investigator title: Medical Doctor, Research Fellow
mesh term: Death, Sudden, Cardiac
mesh term: Long QT Syndrome
mesh term: Romano-Ward Syndrome
mesh term: Death
mesh term: Spironolactone
mesh term: Adrenergic beta-Antagonists
sharing ipd: Undecided