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/NCT06029192</url>
    </required_header>
    <id_info>
      <org_study_id>ECHO-DM1</org_study_id>
      <nct_id>NCT06029192</nct_id>
    </id_info>
    <brief_title>Diastolic Function in Myotonic Dystrophy Type 1</brief_title>
    <official_title>Diastolic Function in Myotonic Dystrophy Type 1</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre d'Investigation Clinique et Technologique 805</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre d'Investigation Clinique et Technologique 805</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable&#xD;
        expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction&#xD;
        disorders. Mortality are mainly related to respiratory failure and sudden death. Patients&#xD;
        with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea.&#xD;
        These comorbidities are classically associated with left ventricular diastolic dysfunction&#xD;
        (DD) .&#xD;
  &#xD;
        The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in&#xD;
        patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the&#xD;
        long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 2, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>mortality</measure>
      <time_frame>7 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of arrhythmia</measure>
      <time_frame>7 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>acute heart failure</measure>
      <time_frame>7 years</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Diastolic Dysfunction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients with myotonic dystrophy type 1 followed in a tertiary reference center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with genetic proven myotonic dystrophy type 1&#xD;
  &#xD;
            -  who experienced a Doppler- Echocardiography including an assessment of the left&#xD;
               ventricular diastolic function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  wall motion basal abnormalities&#xD;
  &#xD;
            -  significant valvular disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Abdallah FAYSSOIL, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Raymond Poincare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abdallah FAYSSOIL, MD PhD</last_name>
      <phone>+33147107778</phone>
      <email>abdallah.fayssoil@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hopital Raymond Poincare</name>
        <address>
          <city>Garches</city>
          <zip>92380</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ABDALLAH FAYSSOIL, MDPhD</last_name>
        <phone>003347101411</phone>
        <email>abdallah.fayssoil@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre d'Investigation Clinique et Technologique 805</investigator_affiliation>
      <investigator_full_name>Abdallah FAYSSOIL</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myotonic Dystrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06029192
  org study id: ECHO-DM1
  nct id: NCT06029192
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable
        expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction
        disorders. Mortality are mainly related to respiratory failure and sudden death. Patients
        with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea.
        These comorbidities are classically associated with left ventricular diastolic dysfunction
        (DD) .
  
        The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in
        patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the
        long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.
  observational model: Cohort
  time perspective: Retrospective
  measure: mortality
  time frame: 7 years
  measure: Incidence of arrhythmia
  time frame: 7 years
  measure: acute heart failure
  time frame: 7 years
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Abdallah FAYSSOIL, MD PhD
  role: Principal Investigator
  affiliation: CHU Raymond Poincare
  last name: Abdallah FAYSSOIL, MD PhD
  phone: +33147107778
  email: abdallah.fayssoil@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Centre d'Investigation Clinique et Technologique 805
  investigator full name: Abdallah FAYSSOIL
  investigator title: Associate Professor
  mesh term: Myotonic Dystrophy
  sharing ipd: No