<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/NCT01728025</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-SV-0363-10-CTIL</org_study_id>
    <nct_id>NCT01728025</nct_id>
  </id_info>
  <brief_title>Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether ranolazine will reduce the risk of&#xD;
      arrhythmic events in patients with long QT syndrome type 3.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with syncope and/or documented ventricular arrhythmia</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in corrected QT interval</measure>
    <time_frame>within 30 days of initiation of Ranolazine treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Long QT Syndrome Type 3</condition>
  <arm_group>
    <arm_group_label>Ranolazine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ranolazine 500-1000 mg twice a day as tolerated</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranolazine</intervention_name>
    <arm_group_label>Ranolazine</arm_group_label>
    <other_name>Ranexa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Long QT patients with genetic confirmation of carrier-status for the D1790G mutation&#xD;
             in the SCN5A gene&#xD;
&#xD;
          -  Corrected QT interval &gt; 460 msec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for therapy with medications that are potent or moderately potent CYP3A&#xD;
             inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV&#xD;
             protease inhibitors)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sami Viskin, MD</last_name>
    <phone>972-3-6973311</phone>
    <email>samiviskin@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jesaia Benhorin, MD</last_name>
    <phone>972-3-6973311</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sami Viskin, MD</last_name>
      <phone>972-3-6973311</phone>
      <email>samiviskin@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sami Viskin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jesaia Benhorin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arnon Adler, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Moss AJ, Zareba W, Schwarz KQ, Rosero S, McNitt S, Robinson JL. Ranolazine shortens repolarization in patients with sustained inward sodium current due to type-3 long-QT syndrome. J Cardiovasc Electrophysiol. 2008 Dec;19(12):1289-93. doi: 10.1111/j.1540-8167.2008.01246.x. Epub 2008 Jul 25.</citation>
    <PMID>18662191</PMID>
  </reference>
  <reference>
    <citation>Lindegger N, Hagen BM, Marks AR, Lederer WJ, Kass RS. Diastolic transient inward current in long QT syndrome type 3 is caused by Ca2+ overload and inhibited by ranolazine. J Mol Cell Cardiol. 2009 Aug;47(2):326-34. doi: 10.1016/j.yjmcc.2009.04.003. Epub 2009 Apr 14.</citation>
    <PMID>19371746</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long QT syndrome</keyword>
  <keyword>Ranolazine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Long QT Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranolazine</mesh_term>
  </intervention_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/NCT01728025
org study id: TASMC-12-SV-0363-10-CTIL
nct id: NCT01728025
lead sponsor: 
The purpose of this study is to determine whether ranolazine will reduce the risk of
      arrhythmic events in patients with long QT syndrome type 3.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with syncope and/or documented ventricular arrhythmia
time frame: 5 years
measure: Change in corrected QT interval
time frame: within 30 days of initiation of Ranolazine treatment
arm group label: Ranolazine
arm group type: Experimental
description: Ranolazine 500-1000 mg twice a day as tolerated
intervention type: Drug
intervention name: Ranolazine
arm group label: Ranolazine
other name: Ranexa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sami Viskin, MD
phone: 972-3-6973311
email: samiviskin@gmail.com
last name: Jesaia Benhorin, MD
phone: 972-3-6973311
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Israel
citation: Moss AJ, Zareba W, Schwarz KQ, Rosero S, McNitt S, Robinson JL. Ranolazine shortens repolarization in patients with sustained inward sodium current due to type-3 long-QT syndrome. J Cardiovasc Electrophysiol. 2008 Dec;19(12):1289-93. doi: 10.1111/j.1540-8167.2008.01246.x. Epub 2008 Jul 25.
PMID: 18662191
citation: Lindegger N, Hagen BM, Marks AR, Lederer WJ, Kass RS. Diastolic transient inward current in long QT syndrome type 3 is caused by Ca2+ overload and inhibited by ranolazine. J Mol Cell Cardiol. 2009 Aug;47(2):326-34. doi: 10.1016/j.yjmcc.2009.04.003. Epub 2009 Apr 14.
PMID: 19371746
responsible party type: Sponsor
mesh term: Long QT Syndrome
mesh term: Syndrome
mesh term: Ranolazine