<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/NCT01704183</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2012-SS</org_study_id>
    <secondary_id>2012-002694-66</secondary_id>
    <nct_id>NCT01704183</nct_id>
  </id_info>
  <brief_title>Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis</brief_title>
  <acronym>FingoHRV</acronym>
  <official_title>Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to study the effect of fingolimod on cardiac autonomic&#xD;
      regulation in patients with relapse-remitting multiple sclerosis.&#xD;
&#xD;
      This will be done by measuring heart rate variability from the 24-hour Holter recording and&#xD;
      myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.&#xD;
&#xD;
      The fingolimod treatment is prescribed according to the accepted drug label.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart&#xD;
      rate variability and myocardial ventricular repolarisation pattern will be done 1) before&#xD;
      fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of&#xD;
      fingolimod.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>change in heart rate variability</measure>
    <time_frame>prior medication vs initiation vs 3 month</time_frame>
  </primary_outcome>
  <enrollment type="Actual">27</enrollment>
  <condition>Relapse-remitting Multiple Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Neurological clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 65 years&#xD;
&#xD;
          -  Understands the proposed research and actions to be taken&#xD;
&#xD;
          -  The written informed consent has given&#xD;
&#xD;
          -  clinical indication to fingolimod-treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refuses&#xD;
&#xD;
          -  Patient takes or has taken part in other clinical drug trial during the last month&#xD;
&#xD;
          -  No clinical indication to the use of fingolimod&#xD;
&#xD;
          -  Contraindication to the use of fingolimod&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sakari Simula, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Mikkeli Central Hospital, Department of Neurology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Päivi Hartikainen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Kuopio University Hospital, Neuro Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juha Hartikainen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Kuopio University Hospital, Heart Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neuro Center, Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Mikkeli Central Hospital</name>
      <address>
        <city>Mikkeli</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>May 7, 2014</last_update_submitted>
  <last_update_submitted_qc>May 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>relapse-remitting multiple sclerosis</keyword>
  <keyword>heart rate variability</keyword>
  <keyword>fingolimod</keyword>
  <keyword>cardiac autonomic regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Recurrence</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/NCT01704183
org study id: IIT-2012-SS
secondary id: 2012-002694-66
nct id: NCT01704183
lead sponsor: 
The purpose of this study is to study the effect of fingolimod on cardiac autonomic
      regulation in patients with relapse-remitting multiple sclerosis.

      This will be done by measuring heart rate variability from the 24-hour Holter recording and
      myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.

      The fingolimod treatment is prescribed according to the accepted drug label.
The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart
      rate variability and myocardial ventricular repolarisation pattern will be done 1) before
      fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of
      fingolimod.
observational model: Cohort
time perspective: Prospective
measure: change in heart rate variability
time frame: prior medication vs initiation vs 3 month
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sakari Simula, MD, PhD
role: Study Director
affiliation: Mikkeli Central Hospital, Department of Neurology
last name: Päivi Hartikainen, MD, PhD
role: Study Director
affiliation: Kuopio University Hospital, Neuro Center
last name: Juha Hartikainen, MD, PhD
role: Study Director
affiliation: Kuopio University Hospital, Heart Center
facility: 
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Recurrence