<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/NCT03237858</url>
  </required_header>
  <id_info>
    <org_study_id>92125179</org_study_id>
    <nct_id>NCT03237858</nct_id>
  </id_info>
  <brief_title>Multiple Cardiac Sensors for the Management of Heart Failure</brief_title>
  <acronym>MANAGE-HF</acronym>
  <official_title>Multiple Cardiac Sensors for the Management of Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</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 MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial&#xD;
      intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic&#xD;
      feature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical&#xD;
      integration of HeartLogic for managing patients with heart failure. There are no endpoints.&#xD;
&#xD;
      Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring&#xD;
      of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the&#xD;
      diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart&#xD;
      rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure&#xD;
      is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to&#xD;
      drive heart failure care against patients with remote monitoring but without HeartLogic&#xD;
      alerts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality and heart failure hospitalization</measure>
    <time_frame>From each patients randomization through final endpoint accrual</time_frame>
    <description>Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic versus those not managed with HeartLogic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from all-cause mortality</measure>
    <time_frame>Subjects that have survived the entire follow-up will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first.</time_frame>
    <description>This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from heart failure hospitalizations (time-to-first event)</measure>
    <time_frame>Subjects that have survived without experiencing a heart failure hospitalization at the time of analysis will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first</time_frame>
    <description>This endpoint will compare the Kaplan-Meier curves of freedom from heart failure hospitalizations between the HeartLogic and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of multiple heart failure hospitalizations</measure>
    <time_frame>All heart failure hospitalizations following randomization for each subject in Phase II will contribute to the analysis</time_frame>
    <description>This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA classification</measure>
    <time_frame>Baseline and 12 months.</time_frame>
    <description>Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Baseline and 12 months.</time_frame>
    <description>Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NT-proBNP</measure>
    <time_frame>Baseline and 12 months.</time_frame>
    <description>Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Status</measure>
    <time_frame>From each patients randomization through final endpoint accrual.</time_frame>
    <description>Change in medication status throughout the study will be evaluated and compared between the randomized groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2700</enrollment>
  <condition>Heart Failure, Congestive</condition>
  <arm_group>
    <arm_group_label>HeartLogic ON</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ICD and CRT-D devices with HeartLogic alerts turned ON</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HeartLogic OFF</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ICD and CRT-D devices with HeartLogic alerts turned OFF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartLogic ON</intervention_name>
    <description>Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF</description>
    <arm_group_label>HeartLogic ON</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartLogic OFF</intervention_name>
    <description>Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON</description>
    <arm_group_label>HeartLogic OFF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is age 18 or above, or of legal age to give informed consent&#xD;
&#xD;
          2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or&#xD;
             implantable cardioverter-defibrillator (ICD) device that has HeartLogic&#xD;
&#xD;
          3. Current symptomatic heart failure or New York Heart Association Class II or III at the&#xD;
             time of enrollment&#xD;
&#xD;
          4. Remotely monitored by LATITUDE 5.0 (or future versions)&#xD;
&#xD;
          5. Willing and capable of participating in all study visits and complying with&#xD;
             medication/treatment requirements associated with this clinical study at an approved&#xD;
             clinical study center.&#xD;
&#xD;
          6. Meet at least one of the three following conditions:&#xD;
&#xD;
               -  At least one documented hospitalization with a primary diagnosis of worsening for&#xD;
                  heart failure during the 12 months prior to enrollment; or&#xD;
&#xD;
               -  Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF&#xD;
                  during 90 days prior to enrollment; or&#xD;
&#xD;
               -  N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or&#xD;
                  brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days&#xD;
                  prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is unable to sign or refuses to sign the patient informed consent&#xD;
&#xD;
          2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time&#xD;
             of enrollment&#xD;
&#xD;
          3. The subject is implanted with unipolar right atrial or right ventricular leads&#xD;
&#xD;
          4. Subject has received or is scheduled to receive a heart transplant or ventricular&#xD;
             assist device within the next 6 months&#xD;
&#xD;
          5. Subject is pregnant or planning to become pregnant during the study&#xD;
&#xD;
          6. Subject is enrolled in any other concurrent study (without prior written approval from&#xD;
             Boston Scientific, excluding registries)&#xD;
&#xD;
          7. Glomerular filtration rate &lt;25 mL/min who are non-responsive to diuretic therapy or&#xD;
             are on chronic renal dialysis&#xD;
&#xD;
          8. Regularly scheduled intravenous heart failure therapy (for example inotropes or&#xD;
             diuretics)&#xD;
&#xD;
          9. A life expectancy of less than 12 months per clinician discretion&#xD;
&#xD;
         10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF&#xD;
&#xD;
         11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at&#xD;
             anytime within the past 6 months.&#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>Adrian Hernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Center Research, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Northeast Arkansas</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Hospital, Inc.</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Cardiovascular Specialists</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centra Care Heart and Vascular Center</name>
      <address>
        <city>Cold Spring</city>
        <state>Minnesota</state>
        <zip>56320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Heart and Vascular</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic Medical Center</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strong Memorial Hospital of the University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center for Research and Education at Christ Hosp</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Sacred Heart Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Consultants of Philadelphia</name>
      <address>
        <city>Yardley</city>
        <state>Pennsylvania</state>
        <zip>19067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stern Cardiovascular</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Texas Clinical Research Center</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L'Hôpital privé du Confluent</name>
      <address>
        <city>Nantes</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg AöR</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>diagnostics</keyword>
  <keyword>heart sounds</keyword>
  <keyword>CRT-D</keyword>
  <keyword>ICD</keyword>
  <keyword>remote monitoring</keyword>
  <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/NCT03237858
org study id: 92125179
nct id: NCT03237858
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial
      intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic
      feature.
Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical
      integration of HeartLogic for managing patients with heart failure. There are no endpoints.

      Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring
      of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the
      diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart
      rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure
      is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to
      drive heart failure care against patients with remote monitoring but without HeartLogic
      alerts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: All cause mortality and heart failure hospitalization
time frame: From each patients randomization through final endpoint accrual
description: Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic versus those not managed with HeartLogic.
measure: Freedom from all-cause mortality
time frame: Subjects that have survived the entire follow-up will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first.
description: This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups.
measure: Freedom from heart failure hospitalizations (time-to-first event)
time frame: Subjects that have survived without experiencing a heart failure hospitalization at the time of analysis will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first
description: This endpoint will compare the Kaplan-Meier curves of freedom from heart failure hospitalizations between the HeartLogic and control groups
measure: Risk of multiple heart failure hospitalizations
time frame: All heart failure hospitalizations following randomization for each subject in Phase II will contribute to the analysis
description: This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups.
measure: Change in NYHA classification
time frame: Baseline and 12 months.
description: Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups.
measure: Change in Quality of Life
time frame: Baseline and 12 months.
description: Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups .
measure: Change in NT-proBNP
time frame: Baseline and 12 months.
description: Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups.
measure: Change in Medication Status
time frame: From each patients randomization through final endpoint accrual.
description: Change in medication status throughout the study will be evaluated and compared between the randomized groups.
arm group label: HeartLogic ON
arm group type: Active Comparator
description: ICD and CRT-D devices with HeartLogic alerts turned ON
arm group label: HeartLogic OFF
arm group type: Placebo Comparator
description: ICD and CRT-D devices with HeartLogic alerts turned OFF
intervention type: Device
intervention name: HeartLogic ON
description: Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
arm group label: HeartLogic ON
intervention type: Device
intervention name: HeartLogic OFF
description: Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
arm group label: HeartLogic OFF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adrian Hernandez, MD
role: Principal Investigator
affiliation: Duke University
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country: France
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No