<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/NCT04504188</url>
  </required_header>
  <id_info>
    <org_study_id>90D0229</org_study_id>
    <nct_id>NCT04504188</nct_id>
  </id_info>
  <brief_title>Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator</brief_title>
  <acronym>OPT-BB WOMEN</acronym>
  <official_title>Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zoll Medical Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this pilot study is to document the percentage achievement in&#xD;
      effective HR control (average nighttime HR &lt; 70 bpm) during WCD use in a cohort of female&#xD;
      patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends&#xD;
      data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this pilot study is to document the percentage achievement in&#xD;
      effective HR control (average nighttime HR &lt; 70 bpm) during WCD use in a cohort of female&#xD;
      patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends&#xD;
      data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical&#xD;
      control.&#xD;
&#xD;
      Adult female patients (18 years or older) who are prescribed the wearable cardioverter&#xD;
      defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low&#xD;
      ejection fraction.&#xD;
&#xD;
      Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will&#xD;
      be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will&#xD;
      be emailed to the healthcare provider. The healthcare provider will also receive a HR control&#xD;
      alert if the HR exceeds a predetermined threshold for 3 days in a row.&#xD;
&#xD;
      Based on this information, clinicians should follow guideline-directed medical therapy (GDMT)&#xD;
      to add or titrate medication accordingly. The goal of these changes will be to achieve the&#xD;
      average nighttime HR to recommended guidelines (&lt;70 bpm) by the end of WCD use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>
    <intervention_model_description>Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.&#xD;
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (&lt;70 bpm) by the end of WCD use.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Control</measure>
    <time_frame>90 days</time_frame>
    <description>The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR &lt; 70 bpm) during WCD use in female patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Control in Ischemic vs. Non-ischemic Patients</measure>
    <time_frame>90 days</time_frame>
    <description>To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Average Nighttime Resting Heart Rate</measure>
    <time_frame>90 days</time_frame>
    <description>Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)</measure>
    <time_frame>90 days</time_frame>
    <description>To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)</measure>
    <time_frame>90 days</time_frame>
    <description>To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Functional Capacity</measure>
    <time_frame>90 days</time_frame>
    <description>To observe changes in functional capacity as measured by average daily step count over the course of WCD use.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Rate Monitor Enhanced Treatment Optimization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heart Rate Monitor Enhanced Treatment Optimization</intervention_name>
    <description>Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.</description>
    <arm_group_label>Heart Rate Monitor Enhanced Treatment Optimization</arm_group_label>
    <other_name>LifeVest Wearable Cardioverter Defibrillator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Screening Phase:&#xD;
&#xD;
          -  Female patients with newly diagnosed (never hospitalized for HF in the last 30 days&#xD;
             prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the&#xD;
             time of WCD prescription.&#xD;
&#xD;
          -  Patients prescribed the WCD for an intended 90 ± 14 days of use.&#xD;
&#xD;
          -  Patients have used the WCD for no more than 14 days from the day of consent.&#xD;
&#xD;
          -  Patients 18 years of age or older at the time of consent.&#xD;
&#xD;
        Inclusion Criteria for Continuation Phase:&#xD;
&#xD;
        -After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105&#xD;
        hours of WCD wear per week (or 15 hours/day) are eligible to continue.&#xD;
&#xD;
        Exclusion Criteria for Screening Phase:&#xD;
&#xD;
          -  Patients with a known contraindication or intolerance to beta-blocker therapy.&#xD;
&#xD;
          -  Patients with permanent atrial fibrillation.&#xD;
&#xD;
          -  Patients who have a pacemaker.&#xD;
&#xD;
          -  Patients with a current or prior implantable cardioverter defibrillator (ICD).&#xD;
&#xD;
          -  Patients who are self-reporting to be pregnant.&#xD;
&#xD;
          -  Patients with known congenital or inherited heart disease.&#xD;
&#xD;
          -  Patients participating in another interventional clinical trial.&#xD;
&#xD;
          -  Patients not expected to live longer than 3 months.&#xD;
&#xD;
        Exclusion Criteria for Continuation Phase:&#xD;
&#xD;
        -Patients ending WCD use within the first two weeks of use.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valentina Kutyifa, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mike Osz</last_name>
    <phone>412-968-3333</phone>
    <email>mosz@zoll.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tara Roberts</last_name>
    <phone>412-968-3333</phone>
    <email>tara.roberts@zoll.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas Cardiology Associates of Houston</name>
      <address>
        <city>Kingwood</city>
        <state>Texas</state>
        <zip>77339</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salazar, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CardioVoyage</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75020</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abo-Auda, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CAMC</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</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>Cardiomyopathies</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/NCT04504188
org study id: 90D0229
nct id: NCT04504188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The primary objective of this pilot study is to document the percentage achievement in
      effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female
      patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends
      data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical
      control.
The primary objective of this pilot study is to document the percentage achievement in
      effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female
      patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends
      data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical
      control.

      Adult female patients (18 years or older) who are prescribed the wearable cardioverter
      defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low
      ejection fraction.

      Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will
      be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will
      be emailed to the healthcare provider. The healthcare provider will also receive a HR control
      alert if the HR exceeds a predetermined threshold for 3 days in a row.

      Based on this information, clinicians should follow guideline-directed medical therapy (GDMT)
      to add or titrate medication accordingly. The goal of these changes will be to achieve the
      average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
primary purpose: Treatment
masking: None (Open Label)
measure: Heart Rate Control
time frame: 90 days
description: The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in female patients.
measure: Heart Rate Control in Ischemic vs. Non-ischemic Patients
time frame: 90 days
description: To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
measure: Change in Average Nighttime Resting Heart Rate
time frame: 90 days
description: Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
measure: Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
time frame: 90 days
description: To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100)
measure: Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
time frame: 90 days
description: To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100)
measure: Changes in Functional Capacity
time frame: 90 days
description: To observe changes in functional capacity as measured by average daily step count over the course of WCD use.
arm group label: Heart Rate Monitor Enhanced Treatment Optimization
arm group type: Experimental
description: Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.
intervention type: Device
intervention name: Heart Rate Monitor Enhanced Treatment Optimization
description: Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
arm group label: Heart Rate Monitor Enhanced Treatment Optimization
other name: LifeVest Wearable Cardioverter Defibrillator
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valentina Kutyifa, MD PHD
role: Principal Investigator
affiliation: University of Rochester
last name: Mike Osz
phone: 412-968-3333
email: mosz@zoll.com
last name: Tara Roberts
phone: 412-968-3333
email: tara.roberts@zoll.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
country: United States
responsible party type: Sponsor
mesh term: Cardiomyopathies
sharing ipd: No