<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/NCT04440254</url>
  </required_header>
  <id_info>
    <org_study_id>C19-57</org_study_id>
    <nct_id>NCT04440254</nct_id>
  </id_info>
  <brief_title>Long Duration Holter ECG in Fabry Disease</brief_title>
  <official_title>Natural History of Cardiac Rhythm and Conduction Disorders in Patients With Fabry Disease Evaluated by Long-Term Implantable Holter ECG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to assess the occurrence of cardiac arrhythmias and conduction&#xD;
      disorders during a three-year follow-up using implantable Holter ECG monitoring in 40&#xD;
      patients with Fabry disease. The secondary objectives are to analyze the correlations of&#xD;
      these anomalies with changes in cardiac MRI and echocardiographic parameters as biological&#xD;
      parameters and overall severity of the disease assessed by MSSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this non-blinded, monocentric non-randomized study is to assess the&#xD;
      occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block&#xD;
      [BB], atrioventricular block [BAV], sustained [TVS] or non-supported [TVNS] ventricular&#xD;
      tachycardias, atrial fibrillation [AF] during a three-year follow-up in 40 patients with&#xD;
      Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device&#xD;
      (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2&#xD;
      and 3 years) of these anomalies with the modifications of :&#xD;
&#xD;
        -  cardiac MRI [Magnetic Resonance Imaging] data at inclusion [M0] and at 36 months [M36]&#xD;
           (left ventricular hypertrophy [HVG], amplitude of the T1 signal, extent of fibrosis);&#xD;
           MRIs will be performed before implantation and after removal of the Holter to avoid the&#xD;
           reading artifacts linked to the device.&#xD;
&#xD;
        -  echocardiographic measurements of the left ventricle (overall longitudinal strain&#xD;
           systolic [SGL] and ejection fraction [FE])&#xD;
&#xD;
        -  biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)&#xD;
&#xD;
        -  the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG&#xD;
           and proteinuria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2025</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of cardiac arrhythmias and conduction disorders</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlations between electrical disorders and changes in MRI/ultrasonic data (LV mass, T1 signal, fibrosis extent , systolic strain, ejection fraction), concentrations of BNP, troponin, Lyso-Gb3, MSSI score and renal function</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Fabry Disease</condition>
  <arm_group>
    <arm_group_label>ONE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One single group of patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device</intervention_name>
    <description>Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region</description>
    <arm_group_label>ONE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patient&#xD;
&#xD;
          -  Age greater than or equal to 18 years on the day of inclusion&#xD;
&#xD;
          -  Presence of a morbid mutation for MF&#xD;
&#xD;
          -  Signature of the informed consent form&#xD;
&#xD;
          -  Absence of significant valve disease, verified on medical file (absence stenosis or&#xD;
             regurgitation &lt;2+ in color Doppler on a scale 1 to 4+ by extension of the jet)&#xD;
&#xD;
          -  No history of known or documented myocardial infarction nor CAD&#xD;
&#xD;
          -  No pacemaker or ICD&#xD;
&#xD;
          -  no history of AF, NSVT, high-degree AV block&#xD;
&#xD;
          -  Correct echogenicity&#xD;
&#xD;
          -  No treatment by corticosteroid or immunosuppressive drugs&#xD;
&#xD;
          -  creatinine clearance &gt;/= 30 Ml/mn&#xD;
&#xD;
          -  LVEF ≥ 50% by ultrasound and / or MRI&#xD;
&#xD;
          -  No contraindication to MRI (or claustrophobia) and gadolinium injection&#xD;
&#xD;
          -  Affiliation to the French social security insurance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fabry Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04440254
org study id: C19-57
nct id: NCT04440254
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The main objective is to assess the occurrence of cardiac arrhythmias and conduction
      disorders during a three-year follow-up using implantable Holter ECG monitoring in 40
      patients with Fabry disease. The secondary objectives are to analyze the correlations of
      these anomalies with changes in cardiac MRI and echocardiographic parameters as biological
      parameters and overall severity of the disease assessed by MSSI.
The main objective of this non-blinded, monocentric non-randomized study is to assess the
      occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block
      [BB], atrioventricular block [BAV], sustained [TVS] or non-supported [TVNS] ventricular
      tachycardias, atrial fibrillation [AF] during a three-year follow-up in 40 patients with
      Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device
      (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2
      and 3 years) of these anomalies with the modifications of :

        -  cardiac MRI [Magnetic Resonance Imaging] data at inclusion [M0] and at 36 months [M36]
           (left ventricular hypertrophy [HVG], amplitude of the T1 signal, extent of fibrosis);
           MRIs will be performed before implantation and after removal of the Holter to avoid the
           reading artifacts linked to the device.

        -  echocardiographic measurements of the left ventricle (overall longitudinal strain
           systolic [SGL] and ejection fraction [FE])

        -  biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)

        -  the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG
           and proteinuria
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Occurrence of cardiac arrhythmias and conduction disorders
time frame: 3 years
measure: Correlations between electrical disorders and changes in MRI/ultrasonic data (LV mass, T1 signal, fibrosis extent , systolic strain, ejection fraction), concentrations of BNP, troponin, Lyso-Gb3, MSSI score and renal function
time frame: 3 years
arm group label: ONE
arm group type: Other
description: One single group of patients
intervention type: Diagnostic Test
intervention name: Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device
description: Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region
arm group label: ONE
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fabry Disease
sharing ipd: No