xml: <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/NCT05988749</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2023-0529</org_study_id>
      <nct_id>NCT05988749</nct_id>
    </id_info>
    <brief_title>Digital Remote Home Monitoring for Heart Failure</brief_title>
    <acronym>ADHERE-HF</acronym>
    <official_title>American Heart Association Digital Home Remote Monitoring for Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Texas Southwestern Medical Center</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>
        We will enroll 150 adult participants with systolic heart failure into the ADHERE-HF trial.&#xD;
        The study will randomize participants in a 1:2 fashion to usual care or usual care plus the&#xD;
        American Heart Association's Digital Solution for 90 days. This wearable device and careplan&#xD;
        package is hypothesized to improve rates of guideline directed heart failure medical care for&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background/Rationale:&#xD;
  &#xD;
        Guideline-directed medical therapy (GDMT) is a cornerstone of the management of individuals&#xD;
        with heart failure with reduced ejection fraction (HFrEF). Patients on optimal heart failure&#xD;
        pharmacotherapy experience higher survival rates and fewer heart failure hospitalizations&#xD;
        compared with subjects not on these medications [1,2]. Furthermore, optimal compliance with&#xD;
        these treatments among patients with heart failure is associated with fewer have fewer&#xD;
        emergency department visits, fewer hospital admissions, shorter lengths of hospital stay, and&#xD;
        lower risk of death [3,4].&#xD;
  &#xD;
        Despite very strong evidence for these treatments, a substantial proportion of eligible&#xD;
        subjects with HFrEF are not on GDMT at optimal dosages. Data from the CHAMP-HF registry&#xD;
        demonstrate that fewer than one in four HFrEF subjects are on all three of GDMT medications -&#xD;
        beta-blockers; angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker&#xD;
        (ARB), or angiotensin receptor neprilysin inhibitor (ARNI); and mineralocorticoid receptor&#xD;
        antagonist (MRA) - and only 1% were receiving target doses of all three medications [4].&#xD;
        Published data for both UT-Southwestern and Parkland Health System have demonstrated that&#xD;
        rates of GDMT are above national averages but remain suboptimal with significant room for&#xD;
        improvement.&#xD;
  &#xD;
        Successful interventions to increase the number of subjects of prescribed GDMT at optimal&#xD;
        doses often have included multidisciplinary heart failure clinics that include advanced&#xD;
        practice providers and/or pharmacists with frequent visits [5,6]. However, such strategies&#xD;
        are resource-intensive and are not widely applicable to heart failure management outside of&#xD;
        specialized heart failure clinics. Health systems, such as Parkland Health System and&#xD;
        UT-Southwestern, have also considered and purchased remote home monitoring programs for&#xD;
        patients with systolic heart failure to try to improve prescription rates of GDMT. However,&#xD;
        few studies have evaluated the impact of remote home monitoring on rates of GDMT in highly&#xD;
        diverse patient populations or patients with increased socioeconomic risk.&#xD;
  &#xD;
        As such, there is a crucial unmet need to implement highly effective GDMT titration&#xD;
        strategies in heart failure populations with increased socioeconomic risk and the effects of&#xD;
        remote monitoring systems to improve GDMT are not well known.&#xD;
  &#xD;
        To address this gap in knowledge, we will leverage the large, multiethnic heart failure&#xD;
        populations followed in two health systems, UT-Southwestern and Parkland Health System. Using&#xD;
        these racially and ethnically diverse patient populations, we will test our central&#xD;
        hypothesis that the AHA Digital Platform will improve outcomes in patients with HFrEF by&#xD;
        managing the initiation and titration of heart failure GDMT in comparison with clinical care.&#xD;
        The purpose of this study is to assess the effectiveness of the remote monitoring AHA Digital&#xD;
        Platform to improve initiation and titration of GDMT in addition to traditional clinical&#xD;
        encounters. The effective comparison will be to the current standard of care for heart&#xD;
        failure used in the respective clinical sites.&#xD;
  &#xD;
        The AHA Digital platform integrates data from remote wireless vital signs collection devices&#xD;
        and an investigational wearable health device to recommend optimal titration of GDMT in&#xD;
        subjects with heart failure with reduced ejection fraction (HFrEF) subjects or HFrEF subjects&#xD;
        on suboptimal doses of GDMT. The platform uses a proprietary algorithm to interpret the&#xD;
        remote vitals data collected and presents titration recommendations back to the healthcare&#xD;
        provider (HCP) via a HCP mobile App for subjects randomized to the Intervention Arm at&#xD;
        his/her site. Vitals data and relevant HF educational materials are simultaneously presented&#xD;
        to the subject via a Patient App. Data from an investigational wearable health device is also&#xD;
        provided to both the HCP and subject, however no care decisions are made with the data from&#xD;
        this device. The HCP is also alerted to changes in status of the respective participating&#xD;
        trial subjects via the HCP App and can see aggregated information and further visualize the&#xD;
        status of all subjects enrolled in his/her center via an online web portal.&#xD;
  &#xD;
        Hypothesis We hypothesize that use of the AHA Digital Solution in a real-world, multi-site,&#xD;
        randomized, outpatient study will improve rates and does of optimal Guideline-Directed&#xD;
        Medical Therapy (GDMT) for patients with heart failure with reduced ejection fraction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Single Group Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized in a 1:2 fashion to usual care versus usual care plus the American Heart Association's Digital Solution by dice roll.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>GDMT score</measure>
      <time_frame>0-90 days</time_frame>
      <description>Change in GDMT score from between the intervention and control arm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hospitalized days</measure>
      <time_frame>0-90 days; 0-180 days</time_frame>
      <description>Number of days hospitalized between the intervention and control arm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency room visits</measure>
      <time_frame>0-90 days; 0-180 days</time_frame>
      <description>Number of emergency room visits between the intervention and control arm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GDMT score</measure>
      <time_frame>0-180 days</time_frame>
      <description>Change in GDMT score from between the intervention and control arm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in KCCQ-12 score</measure>
      <time_frame>day 0-90 and 0-180</time_frame>
      <description>Change in overall and subdomain KCCQ-12 scores from between the intervention and control arm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog score change</measure>
      <time_frame>day 0-90</time_frame>
      <description>Change in visual analog scores from between the intervention and control arm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Optimal GDMT dosing</measure>
      <time_frame>0-90 days, 0-180 days</time_frame>
      <description>Difference between the intervention and control arm in the percentage of subjects on optimal doses of GDMT</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient encounters</measure>
      <time_frame>0-90; 0-180 days</time_frame>
      <description>Number of clinical patient encounters (phone, Mychart, clinic visit)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Heart Failure, Systolic</condition>
    <arm_group>
      <arm_group_label>Device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine care for heart failure management</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biofourmis Digital Platform</intervention_name>
      <description>The intervention is a combination of the American Heart Association's Digital Heart Failure CarePlans and Education Content, delivered through and combined with the Biofourmis Platform. Patients enrolled in this arm will wear the device for 90 days and provide data to the participant's care team.</description>
      <arm_group_label>Device</arm_group_label>
      <other_name>American Heart Association's Digital Heart Failure CarePlans and Education Content</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18-year-old adults with a clinical diagnosis of heart failure AND a left ventricular&#xD;
               ejection fraction ≤40% by transthoracic echocardiogram or cardiac MRI within 12 months&#xD;
               prior to enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Patients who are pregnant.&#xD;
  &#xD;
                 -  Prisoners or refugees.&#xD;
  &#xD;
                 -  Patients who are homeless or have unstable housing.&#xD;
  &#xD;
                 -  Unable or unwilling to consent or use study related materials.&#xD;
  &#xD;
                 -  On-going cocaine, methamphetamine, opioid, alcohol, or other illicit substance&#xD;
                    abuse as determined by the study PI.&#xD;
  &#xD;
                 -  Not fluent in English or Spanish.&#xD;
  &#xD;
                 -  Students or trainees at UT-Southwestern or Parkland Health System.&#xD;
  &#xD;
                 -  Enrolled or considering hospice.&#xD;
  &#xD;
                 -  Recent or home inotropic therapy, or heart transplant evaluation.&#xD;
  &#xD;
                 -  Survival anticipated &lt;6 months.&#xD;
  &#xD;
                 -  End-stage renal disease, receiving dialysis or eGFR ≤30 mL/min/1.73m2&#xD;
  &#xD;
                 -  Non-Texas resident&#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>Nicholas Hendren, MD</last_name>
      <phone>214-645-7598</phone>
      <email>nicholas.hendren@utsouthwestern.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
      <investigator_full_name>Nicholas Hendren</investigator_full_name>
      <investigator_title>Assistant Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>remote home monitoring</keyword>
    <keyword>heart failure</keyword>
    <keyword>guideline directed medical therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Heart Failure, Systolic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988749
  org study id: STU-2023-0529
  nct id: NCT05988749
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  We will enroll 150 adult participants with systolic heart failure into the ADHERE-HF trial.
        The study will randomize participants in a 1:2 fashion to usual care or usual care plus the
        American Heart Association's Digital Solution for 90 days. This wearable device and careplan
        package is hypothesized to improve rates of guideline directed heart failure medical care for
        participants.
  Background/Rationale:
  
        Guideline-directed medical therapy (GDMT) is a cornerstone of the management of individuals
        with heart failure with reduced ejection fraction (HFrEF). Patients on optimal heart failure
        pharmacotherapy experience higher survival rates and fewer heart failure hospitalizations
        compared with subjects not on these medications [1,2]. Furthermore, optimal compliance with
        these treatments among patients with heart failure is associated with fewer have fewer
        emergency department visits, fewer hospital admissions, shorter lengths of hospital stay, and
        lower risk of death [3,4].
  
        Despite very strong evidence for these treatments, a substantial proportion of eligible
        subjects with HFrEF are not on GDMT at optimal dosages. Data from the CHAMP-HF registry
        demonstrate that fewer than one in four HFrEF subjects are on all three of GDMT medications -
        beta-blockers; angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker
        (ARB), or angiotensin receptor neprilysin inhibitor (ARNI); and mineralocorticoid receptor
        antagonist (MRA) - and only 1% were receiving target doses of all three medications [4].
        Published data for both UT-Southwestern and Parkland Health System have demonstrated that
        rates of GDMT are above national averages but remain suboptimal with significant room for
        improvement.
  
        Successful interventions to increase the number of subjects of prescribed GDMT at optimal
        doses often have included multidisciplinary heart failure clinics that include advanced
        practice providers and/or pharmacists with frequent visits [5,6]. However, such strategies
        are resource-intensive and are not widely applicable to heart failure management outside of
        specialized heart failure clinics. Health systems, such as Parkland Health System and
        UT-Southwestern, have also considered and purchased remote home monitoring programs for
        patients with systolic heart failure to try to improve prescription rates of GDMT. However,
        few studies have evaluated the impact of remote home monitoring on rates of GDMT in highly
        diverse patient populations or patients with increased socioeconomic risk.
  
        As such, there is a crucial unmet need to implement highly effective GDMT titration
        strategies in heart failure populations with increased socioeconomic risk and the effects of
        remote monitoring systems to improve GDMT are not well known.
  
        To address this gap in knowledge, we will leverage the large, multiethnic heart failure
        populations followed in two health systems, UT-Southwestern and Parkland Health System. Using
        these racially and ethnically diverse patient populations, we will test our central
        hypothesis that the AHA Digital Platform will improve outcomes in patients with HFrEF by
        managing the initiation and titration of heart failure GDMT in comparison with clinical care.
        The purpose of this study is to assess the effectiveness of the remote monitoring AHA Digital
        Platform to improve initiation and titration of GDMT in addition to traditional clinical
        encounters. The effective comparison will be to the current standard of care for heart
        failure used in the respective clinical sites.
  
        The AHA Digital platform integrates data from remote wireless vital signs collection devices
        and an investigational wearable health device to recommend optimal titration of GDMT in
        subjects with heart failure with reduced ejection fraction (HFrEF) subjects or HFrEF subjects
        on suboptimal doses of GDMT. The platform uses a proprietary algorithm to interpret the
        remote vitals data collected and presents titration recommendations back to the healthcare
        provider (HCP) via a HCP mobile App for subjects randomized to the Intervention Arm at
        his/her site. Vitals data and relevant HF educational materials are simultaneously presented
        to the subject via a Patient App. Data from an investigational wearable health device is also
        provided to both the HCP and subject, however no care decisions are made with the data from
        this device. The HCP is also alerted to changes in status of the respective participating
        trial subjects via the HCP App and can see aggregated information and further visualize the
        status of all subjects enrolled in his/her center via an online web portal.
  
        Hypothesis We hypothesize that use of the AHA Digital Solution in a real-world, multi-site,
        randomized, outpatient study will improve rates and does of optimal Guideline-Directed
        Medical Therapy (GDMT) for patients with heart failure with reduced ejection fraction.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: Patients will be randomized in a 1:2 fashion to usual care versus usual care plus the American Heart Association's Digital Solution by dice roll.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: GDMT score
  time frame: 0-90 days
  description: Change in GDMT score from between the intervention and control arm.
  measure: Hospitalized days
  time frame: 0-90 days; 0-180 days
  description: Number of days hospitalized between the intervention and control arm
  measure: Emergency room visits
  time frame: 0-90 days; 0-180 days
  description: Number of emergency room visits between the intervention and control arm
  measure: GDMT score
  time frame: 0-180 days
  description: Change in GDMT score from between the intervention and control arm.
  measure: Change in KCCQ-12 score
  time frame: day 0-90 and 0-180
  description: Change in overall and subdomain KCCQ-12 scores from between the intervention and control arm
  measure: Visual analog score change
  time frame: day 0-90
  description: Change in visual analog scores from between the intervention and control arm
  measure: Optimal GDMT dosing
  time frame: 0-90 days, 0-180 days
  description: Difference between the intervention and control arm in the percentage of subjects on optimal doses of GDMT
  measure: Patient encounters
  time frame: 0-90; 0-180 days
  description: Number of clinical patient encounters (phone, Mychart, clinic visit)
  arm group label: Device
  arm group type: Experimental
  description: Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.
  arm group label: Routine Care
  arm group type: No Intervention
  description: Routine care for heart failure management
  intervention type: Other
  intervention name: Biofourmis Digital Platform
  description: The intervention is a combination of the American Heart Association's Digital Heart Failure CarePlans and Education Content, delivered through and combined with the Biofourmis Platform. Patients enrolled in this arm will wear the device for 90 days and provide data to the participant's care team.
  arm group label: Device
  other name: American Heart Association's Digital Heart Failure CarePlans and Education Content
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicholas Hendren, MD
  phone: 214-645-7598
  email: nicholas.hendren@utsouthwestern.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Nicholas Hendren
  investigator title: Assistant Professor of Medicine
  mesh term: Heart Failure
  mesh term: Heart Failure, Systolic
  sharing ipd: No