<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/NCT04419480</url>
  </required_header>
  <id_info>
    <org_study_id>U19-05-3608</org_study_id>
    <nct_id>NCT04419480</nct_id>
  </id_info>
  <brief_title>Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial</brief_title>
  <acronym>HALO-Shock</acronym>
  <official_title>Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Inova Health Care Services</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic&#xD;
      Monitoring Following Hospitalization for Cardiogenic Shock&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 31, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hierarchical primary endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>Hierarchical endpoint at 6-months, including death (or mortality-equivalent including left ventricular assist device implantation or heart transplantation), recurrent cardiovascular hospitalization, health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score, and change in log-transformed NT-proBNP level from enrollment to 6 months, evaluated by the win ratio according to the Finkelstein-Schoenfeld method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life change from baseline</measure>
    <time_frame>2 months and 6 months</time_frame>
    <description>Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>6 months</time_frame>
    <description>All-cause mortality from enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality or cardiovascular hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>Time to first all-cause mortality or cardiovascular hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-Cause Hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>Time to all-cause hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)</measure>
    <time_frame>6 months</time_frame>
    <description>Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)</measure>
    <time_frame>6 months</time_frame>
    <description>Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achieved guideline directed medical therapy for heart failure</measure>
    <time_frame>6 months</time_frame>
    <description>Achieved guideline directed medical therapy for heart failure with reduced ejection fraction at 6 months, measured by achievement of &gt;50% of the guideline targeted optimal dosing of angiotensin receptor blocker or angiotensin converting enzyme inhibitor or angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.</measure>
    <time_frame>6 months</time_frame>
    <description>Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitor in the high-risk CS population, including device-related or system-related complications or pressure-sensor failures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cardiogenic Shock</condition>
  <condition>Heart Failure</condition>
  <condition>Ambulatory Hemodynamic Monitoring</condition>
  <arm_group>
    <arm_group_label>CardioMEMS Implant Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-CardioMEMS Implant Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization</intervention_name>
    <description>Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.</description>
    <arm_group_label>CardioMEMS Implant Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient&#xD;
             has the capacity to participate in the study and complete the study questionnaires, in&#xD;
             the estimation of the study investigator.&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. NYHA Class III with dyspnea upon mild physical activity, regardless of left&#xD;
             ventricular ejection fraction (LVEF).&#xD;
&#xD;
          4. Survive to discharge during a current hospital admission with cardiogenic shock (CS)&#xD;
             as defined by clinical criteria previously used in cardiogenic shock trials: systolic&#xD;
             blood pressure &lt; 90 mmHg for &gt; 30 minutes or requiring infusion of catecholamines to&#xD;
             maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ&#xD;
             dysfunction such as pulmonary edema or impaired end-organ perfusion including altered&#xD;
             mentation, oliguria with urine output &lt; 30 mL/h, or serum lactate &gt; 2 mmol/L (5).&#xD;
             Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive&#xD;
             pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion&#xD;
             pressure ≥ 15 mmHg with vasoactive agents.&#xD;
&#xD;
          5. Patients must have internet and phone access (to allow communication of the implanted&#xD;
             device with the researchers).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Technical obstacles which pose an inordinately high procedural risk, in the judgment&#xD;
             of the investigator.&#xD;
&#xD;
          2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left&#xD;
             ventricular assist device (LVAD) or recipient of a heart transplantation for the&#xD;
             treatment of cardiogenic shock during the index hospitalization for CS.&#xD;
&#xD;
          3. If of childbearing potential with a positive pregnancy test.&#xD;
&#xD;
          4. Transition to hospice care.&#xD;
&#xD;
          5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device&#xD;
             implantation.&#xD;
&#xD;
          6. Presence of an active, uncontrolled infection.&#xD;
&#xD;
          7. Any condition other than heart failure that could limit survival to less than 6 months&#xD;
&#xD;
          8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.&#xD;
&#xD;
          9. No access to internet or phone.&#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>Shashank Sinha, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inova Fairfax Medical Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inova Fairfax Medical Campus</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</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>Shock, Cardiogenic</mesh_term>
    <mesh_term>Shock</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/NCT04419480
org study id: U19-05-3608
nct id: NCT04419480
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic
      Monitoring Following Hospitalization for Cardiogenic Shock
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hierarchical primary endpoint
time frame: 6 months
description: Hierarchical endpoint at 6-months, including death (or mortality-equivalent including left ventricular assist device implantation or heart transplantation), recurrent cardiovascular hospitalization, health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score, and change in log-transformed NT-proBNP level from enrollment to 6 months, evaluated by the win ratio according to the Finkelstein-Schoenfeld method
measure: Health related quality of life change from baseline
time frame: 2 months and 6 months
description: Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.
measure: All-cause mortality
time frame: 6 months
description: All-cause mortality from enrollment.
measure: All-cause mortality or cardiovascular hospitalization
time frame: 6 months
description: Time to first all-cause mortality or cardiovascular hospitalization.
measure: All-Cause Hospitalization
time frame: 6 months
description: Time to all-cause hospitalization.
measure: Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
time frame: 6 months
description: Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
measure: Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)
time frame: 6 months
description: Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
measure: Achieved guideline directed medical therapy for heart failure
time frame: 6 months
description: Achieved guideline directed medical therapy for heart failure with reduced ejection fraction at 6 months, measured by achievement of >50% of the guideline targeted optimal dosing of angiotensin receptor blocker or angiotensin converting enzyme inhibitor or angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist.
measure: Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.
time frame: 6 months
description: Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitor in the high-risk CS population, including device-related or system-related complications or pressure-sensor failures.
arm group label: CardioMEMS Implant Group
arm group type: Experimental
description: Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
arm group label: Non-CardioMEMS Implant Group
arm group type: No Intervention
description: Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.
intervention type: Device
intervention name: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
description: Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.
arm group label: CardioMEMS Implant Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shashank Sinha, MD MSc
role: Principal Investigator
affiliation: Inova Fairfax Medical Campus
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shock, Cardiogenic
mesh term: Shock
sharing ipd: No