<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/NCT04407845</url>
  </required_header>
  <id_info>
    <org_study_id>00011928 FABRIC</org_study_id>
    <nct_id>NCT04407845</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation in Patients Receiving Ibrutinib</brief_title>
  <acronym>FABRIC</acronym>
  <official_title>Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Georges Pompidou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Georges Pompidou Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in&#xD;
      haematology. According to retrospective data, atrial fibrillation and systemic hypertension&#xD;
      are common ibrutinib-related advserse events. The investigators aim at prospectively&#xD;
      establishing the incidence of thesedrug related advsere events through clinical monitoring&#xD;
      and attempt at identifying populations at risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 21, 2022</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>Incidence of cardiovascular events on ibrutinib</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of supra-ventricular arrythmias</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with supra-ventricular arrythmias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of systemic hypertension</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with systemic hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of arterial embolism</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with systemic hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hemorraghe</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with hemorraghe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety mesures</measure>
    <time_frame>1 year</time_frame>
    <description>Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anticoagulants</measure>
    <time_frame>1 year</time_frame>
    <description>Correlation between anti thrombotic strategies and cardiovascular outcomes</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Leukemia, Chronic Lymphatic</condition>
  <condition>Mantle Cell Lymphoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective consecutive cohort&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients deem to start ibrutinib therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past history of ibrutinib therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mariana Mirabel, MD, PHD</last_name>
    <phone>+33156095636</phone>
    <email>mariana.mirabel@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Paris - Centre Université de Paris</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariana Mirabel, MD, PhD</last_name>
      <phone>+33156095636</phone>
      <email>mariana.mirabel@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>European Georges Pompidou Hospital</investigator_affiliation>
    <investigator_full_name>Mariana Mirabel</investigator_full_name>
    <investigator_title>MD, PhD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>haematology</keyword>
  <keyword>systemic hypertension</keyword>
  <keyword>prognosis</keyword>
  <keyword>heart</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_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/NCT04407845
org study id: 00011928 FABRIC
nct id: NCT04407845
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in
      haematology. According to retrospective data, atrial fibrillation and systemic hypertension
      are common ibrutinib-related advserse events. The investigators aim at prospectively
      establishing the incidence of thesedrug related advsere events through clinical monitoring
      and attempt at identifying populations at risk.
observational model: Cohort
time perspective: Prospective
measure: Incidence of cardiovascular events on ibrutinib
time frame: 6 months
description: Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.
measure: Incidence of supra-ventricular arrythmias
time frame: 6 months
description: Number of patients with supra-ventricular arrythmias
measure: Incidence of systemic hypertension
time frame: 6 months
description: Number of patients with systemic hypertension
measure: Incidence of arterial embolism
time frame: 6 months
description: Number of patients with systemic hypertension
measure: Incidence of hemorraghe
time frame: 6 months
description: Number of patients with hemorraghe
measure: Safety mesures
time frame: 1 year
description: Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib
measure: Anticoagulants
time frame: 1 year
description: Correlation between anti thrombotic strategies and cardiovascular outcomes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mariana Mirabel, MD, PHD
phone: +33156095636
email: mariana.mirabel@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: European Georges Pompidou Hospital
investigator full name: Mariana Mirabel
investigator title: MD, PhD, Associate Professor
mesh term: Lymphoma, Mantle-Cell
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
sharing ipd: Undecided