<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/NCT04413487</url>
  </required_header>
  <id_info>
    <org_study_id>20</org_study_id>
    <nct_id>NCT04413487</nct_id>
  </id_info>
  <brief_title>Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy</brief_title>
  <official_title>Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      Subjects will include patients diagnosed with breast cancer or hematological cancer who are&#xD;
      planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or&#xD;
      more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram&#xD;
      to determine if heart problems can be detected earlier.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline&#xD;
           echocardiogram as per standard protocol which should be covered by the routine insurance&#xD;
&#xD;
        -  Follow-up with an extra echocardiogram for research purposes would be performed after 2&#xD;
           cycles of that chemotherapy - supplied by the study&#xD;
&#xD;
        -  Clinical assessment at 3 to 6 months including repeat echocardiography as per standard&#xD;
           care with the research question as whether any differences in strain pattern between&#xD;
           pre-chemo and post 2 cycles studies all identify patients who are more likely to have&#xD;
           cardiac issues later.&#xD;
&#xD;
        -  Patients will have standard of care visits at 3 month, 6 month and 12 month and will be&#xD;
           evaluated for cardiac status and survival.&#xD;
&#xD;
        -  Patient records will be reviewed at 5 years to check cardiac status and survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study never started due to change in standard of care guideline&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2020</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 28, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in left ventricular ejection fraction (LVEF)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>a decrease in LVEF of ≥10 percentage points from baseline to a value of &lt; 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF &lt;50% for patients who have a baseline LVEF of 50-54%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival status</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>alive or deceased</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptoms that may be indicative of heart failure</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Presence of absence of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in treatment that may be indicative of heart failure</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Presence or absence of treatment for heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in strain echo that may be indicative of heart failure</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Presence or absence of heart failure by imaging</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extra echocardiogram</intervention_name>
    <description>Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will include patients diagnosed with breast cancer or hematological cancer who are&#xD;
        planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or&#xD;
        more risk factors for cardiovascular disease including LVEF 50-54% by baseline&#xD;
        echocardiogram; Age ≥ 65; BMI ≥ 30 kg/m2;current or prior anti-hypertensive therapy;&#xD;
        diagnosis of coronary artery disease (CAD); Diabetes Mellitus or Atrial&#xD;
        fibrillation/flutter.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 18 years and above&#xD;
&#xD;
          -  Willing and able to provide consent&#xD;
&#xD;
          -  Able to read&#xD;
&#xD;
          -  Patients diagnosed with breast cancer or hematological cancer who are planned for&#xD;
             chemotherapy treatment with anthracycline or trastuzumab.&#xD;
&#xD;
          -  Patients at increased risk of cardiotoxicity with one or more risk factors for heart&#xD;
             disease:&#xD;
&#xD;
               -  LVEF 50-54% by baseline echocardiogram&#xD;
&#xD;
               -  Age ≥ 65&#xD;
&#xD;
               -  BMI ≥ 30 kg/m2&#xD;
&#xD;
               -  Current or prior anti-hypertensive therapy&#xD;
&#xD;
               -  Diagnosis of coronary artery disease (CAD)&#xD;
&#xD;
               -  Diabetes Mellitus&#xD;
&#xD;
               -  Atrial fibrillation/flutter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Only single encounter without follow up&#xD;
&#xD;
          -  Cancer diagnosis other than breast or hematological cancer&#xD;
&#xD;
          -  Chemotherapy treatment other than anthracycline or trastuzumab&#xD;
&#xD;
          -  No prior chemotherapy treatment&#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_official>
    <last_name>Philip Lowry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Guthrie Clinic</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 9, 2019</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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>Heart Failure</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/NCT04413487
org study id: 20
nct id: NCT04413487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subjects will include patients diagnosed with breast cancer or hematological cancer who are
      planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or
      more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram
      to determine if heart problems can be detected earlier.
-  Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline
           echocardiogram as per standard protocol which should be covered by the routine insurance

        -  Follow-up with an extra echocardiogram for research purposes would be performed after 2
           cycles of that chemotherapy - supplied by the study

        -  Clinical assessment at 3 to 6 months including repeat echocardiography as per standard
           care with the research question as whether any differences in strain pattern between
           pre-chemo and post 2 cycles studies all identify patients who are more likely to have
           cardiac issues later.

        -  Patients will have standard of care visits at 3 month, 6 month and 12 month and will be
           evaluated for cardiac status and survival.

        -  Patient records will be reviewed at 5 years to check cardiac status and survival.
observational model: Case-Only
time perspective: Prospective
measure: Change in left ventricular ejection fraction (LVEF)
time frame: through study completion, an average of 1 year
description: a decrease in LVEF of ≥10 percentage points from baseline to a value of < 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF <50% for patients who have a baseline LVEF of 50-54%
measure: Survival status
time frame: through study completion, an average of 1 year
description: alive or deceased
measure: Change in symptoms that may be indicative of heart failure
time frame: through study completion, an average of 1 year
description: Presence of absence of symptoms
measure: Change in treatment that may be indicative of heart failure
time frame: through study completion, an average of 1 year
description: Presence or absence of treatment for heart failure
measure: Change in strain echo that may be indicative of heart failure
time frame: through study completion, an average of 1 year
description: Presence or absence of heart failure by imaging
intervention type: Other
intervention name: Extra echocardiogram
description: Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip Lowry, MD
role: Principal Investigator
affiliation: The Guthrie Clinic
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No