<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/NCT03259711</url>
  </required_header>
  <id_info>
    <org_study_id>CIC1421-17-09</org_study_id>
    <nct_id>NCT03259711</nct_id>
  </id_info>
  <brief_title>Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase</brief_title>
  <acronym>SERENA</acronym>
  <official_title>Cardiotoxicity of Selective Estrogen Receptor Modulators and Aromatase Inhibitors in the European Pharmacovigilance Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier Pitie-Salpetriere</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>
      Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast&#xD;
      cancer seems to have an impact on the cardio-vascular system. This study investigates reports&#xD;
      of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC)&#xD;
      classification: L02 in the European pharmacovigilance database, Eudravigilance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hormone replacement therapies and contraceptive pills are responsible of a wide range of&#xD;
      cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart&#xD;
      disease. The difference of incidence and type of cardio-vascular events between men and women&#xD;
      are strongly related to sex hormones. This study investigates the main characteristics of&#xD;
      patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT&#xD;
      prolongation and Torsade de Pointe) imputed to drugs classified as L02 according to ATC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2001</start_date>
  <completion_date type="Actual">August 14, 2017</completion_date>
  <primary_completion_date type="Actual">August 14, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of disproportionality of reports for cardiotoxicity associated with selective estrogen receptor modulators as compared to aromatase inhibitors by performing a case- non-case study</measure>
    <time_frame>Immediate evaluation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of cardiotoxicity (ventricular arrhythmia's, QT prolongation and Torsade de Pointe) depending on the category and type of hormonal therapy (selective estrogen receptor modulators or aromatase inhibitors)</measure>
    <time_frame>Immediate evaluation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors</measure>
    <time_frame>Immediate evaluation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors</measure>
    <time_frame>Immediate evaluation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors</measure>
    <time_frame>Immediate evaluation</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">20000</enrollment>
  <condition>Cardiac Affections</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hormonal therapies L02 in the ATC classification</intervention_name>
    <description>Hormonal therapies L02 in the ATC classification</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population is selected in the Eurodravigilance database from 01/2002 to 08/2017 and&#xD;
        included patients treated with hormonal therapies L02 in the ATC classification.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case reported in the Eudravigilance from 01/2002 to 08/2017&#xD;
&#xD;
          -  Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the&#xD;
             HLT Death and Sudden Death&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joe-Elie Salem, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Grouthier V, Lebrun-Vignes B, Glazer AM, Touraine P, Funck-Brentano C, Pariente A, Courtillot C, Bachelot A, Roden DM, Moslehi JJ, Salem JE. Increased long QT and torsade de pointes reporting on tamoxifen compared with aromatase inhibitors. Heart. 2018 Nov;104(22):1859-1863. doi: 10.1136/heartjnl-2017-312934. Epub 2018 May 2.</citation>
    <PMID>29720397</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Groupe Hospitalier Pitie-Salpetriere</investigator_affiliation>
    <investigator_full_name>Joe Elie Salem</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Cardiotoxicity</keyword>
  <keyword>selective estrogen receptor modulators</keyword>
  <keyword>aromatase inhibitors</keyword>
  <keyword>hormone replacement therapy</keyword>
  <keyword>estrogen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</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/NCT03259711
org study id: CIC1421-17-09
nct id: NCT03259711
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast
      cancer seems to have an impact on the cardio-vascular system. This study investigates reports
      of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC)
      classification: L02 in the European pharmacovigilance database, Eudravigilance.
Hormone replacement therapies and contraceptive pills are responsible of a wide range of
      cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart
      disease. The difference of incidence and type of cardio-vascular events between men and women
      are strongly related to sex hormones. This study investigates the main characteristics of
      patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT
      prolongation and Torsade de Pointe) imputed to drugs classified as L02 according to ATC.
observational model: Case-Only
time perspective: Retrospective
measure: Analysis of disproportionality of reports for cardiotoxicity associated with selective estrogen receptor modulators as compared to aromatase inhibitors by performing a case- non-case study
time frame: Immediate evaluation
measure: Type of cardiotoxicity (ventricular arrhythmia's, QT prolongation and Torsade de Pointe) depending on the category and type of hormonal therapy (selective estrogen receptor modulators or aromatase inhibitors)
time frame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors
time frame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors
time frame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors
time frame: Immediate evaluation
intervention type: Drug
intervention name: Hormonal therapies L02 in the ATC classification
description: Hormonal therapies L02 in the ATC classification
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Joe-Elie Salem, MD, PhD
role: Principal Investigator
affiliation: Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
facility: 
country: France
citation: Grouthier V, Lebrun-Vignes B, Glazer AM, Touraine P, Funck-Brentano C, Pariente A, Courtillot C, Bachelot A, Roden DM, Moslehi JJ, Salem JE. Increased long QT and torsade de pointes reporting on tamoxifen compared with aromatase inhibitors. Heart. 2018 Nov;104(22):1859-1863. doi: 10.1136/heartjnl-2017-312934. Epub 2018 May 2.
PMID: 29720397
responsible party type: Principal Investigator
investigator affiliation: Groupe Hospitalier Pitie-Salpetriere
investigator full name: Joe Elie Salem
investigator title: MD, PhD
mesh term: Cardiotoxicity