<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/NCT04441203</url>
  </required_header>
  <id_info>
    <org_study_id>MHICC-2018-001</org_study_id>
    <nct_id>NCT04441203</nct_id>
  </id_info>
  <brief_title>Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes</brief_title>
  <acronym>SELFIe-HF</acronym>
  <official_title>Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montreal Heart Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management&#xD;
      using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to&#xD;
      decreased: hospital admissions for heart failure (HF), emergency department consultation&#xD;
      and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a&#xD;
      regular HFC, has low device-related complications and is cost-effective, in New York Heart&#xD;
      Association (NYHA) class III and II (requiring diuretics) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE)&#xD;
      trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed&#xD;
      using remote access to hemodynamics compared to a non-implanted control group. Patients with&#xD;
      at least one hospitalization for HF (≥1) in the previous year (12 months) will be randomized&#xD;
      into two groups, regardless of LVEF:&#xD;
&#xD;
      Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or&#xD;
      Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse&#xD;
      clinician and patient empowerment with access to the PAP data (CardioMEMS group).&#xD;
&#xD;
      Primary and secondary endpoints will be compared between groups after 12 months of follow-up&#xD;
      and within groups comparing baseline parameters with 12 month follow-up measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 4, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>
    <intervention_model_description>This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>first occurrence of any component of the composite event</measure>
    <time_frame>12 months</time_frame>
    <description>acute decompensated heart failure requiring emergency department consultation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic</measure>
    <time_frame>12 months</time_frame>
    <description>unplanned intravenous heart failure therapy in an outpatient clinic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with hospital admission for heart failure</measure>
    <time_frame>12 months</time_frame>
    <description>hospital admission for heart failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with cardiovascular (CV) death</measure>
    <time_frame>12 months</time_frame>
    <description>cardiovascular (CV) death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to the first occurrence of the individual components of the primary endpoint</measure>
    <time_frame>12 months</time_frame>
    <description>Acute decompensated heart failure that requires emergency department consultation and/or unplanned intravenous heart failure therapy in an outpatient clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with CV death</measure>
    <time_frame>12 months</time_frame>
    <description>CV death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional capacity between baseline and 12-months</measure>
    <time_frame>12 months</time_frame>
    <description>NYHA functional class (Kansas city cardiomyopathy questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 minutes walk distance</measure>
    <time_frame>12 months</time_frame>
    <description>6 minutes walk distance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with device-related endpoints</measure>
    <time_frame>12 months</time_frame>
    <description>Safety: adverse events related to the device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of successful patient contacts</measure>
    <time_frame>12 months</time_frame>
    <description>Number of successful patient contacts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary artery pressures changes mesured by the CardioMems device</measure>
    <time_frame>12 months</time_frame>
    <description>Pulmonary artery pressures changes mesured by the CardioMems device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 months</time_frame>
    <description>cost-effectiveness ratio</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Heart failure clinic follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CardioMems</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CardioMems</intervention_name>
    <description>novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System</description>
    <arm_group_label>CardioMems</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years old.&#xD;
&#xD;
          2. Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12&#xD;
             months). OR&#xD;
&#xD;
          3. Patient with at least one ER visit or unplanned HF clinic requiring iv diuretics&#xD;
             within 12 months will be eligible if they have in addition a N-terminal pro-BNP&#xD;
             (NT-proBNP) level &gt; 800pg/ml at screening AND NYHA Class II on diuretics (furosemide ≥&#xD;
             40mg qd), III or ambulatory IV.&#xD;
&#xD;
          4. HF with reduced or preserved EF of at least 3 months duration.&#xD;
&#xD;
          5. Minimum technological knowledge either with a smartphone or iPAD for use of the&#xD;
             self-management application, including access to internet.&#xD;
&#xD;
          6. Anatomical criteria&#xD;
&#xD;
               1. PA branch diameter between 7 mm - 15 mm&#xD;
&#xD;
               2. For BMI &gt;35, distance from patient's back to target PA&lt;10cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recent cardiovascular event: Acute coronary syndrome (STEMI/NSTEMI; a small rise in&#xD;
             the troponin level would be expected in this population and is not a contraindication&#xD;
             for enrolment); Percutaneous Coronary Intervention (PCI), new cardiac rhythm&#xD;
             management (CRM) device (pacemaker, ICD and CRT), CRM system revision, lead extraction&#xD;
             or cardiac or other major surgery or transient ischemic attack or stroke within 2&#xD;
             months (3 months of stabilization after CRT or cardiac surgery);&#xD;
&#xD;
          2. Scheduled cardiac surgery;&#xD;
&#xD;
          3. History of pulmonary embolism or recurrent deep vein thrombosis;&#xD;
&#xD;
          4. Persistent NYHA Class IV and ACC/AHA HF Stage D, patients implanted with a ventricular&#xD;
             assist device (VAD), or patients listed for cardiac transplantation and likely to be&#xD;
             transplanted within 12 months;&#xD;
&#xD;
          5. Coexisting severe stenotic valve lesions, endocarditis, obstructive hypertrophic&#xD;
             cardiomyopathy, acute myocarditis, tamponade, or large pericardial effusion;&#xD;
&#xD;
          6. Clinically too unstable to be followed remotely; this includes but is not limited to:&#xD;
&#xD;
               1. Resting systolic blood pressure &lt; 80 or &gt; 180 mmHg;&#xD;
&#xD;
               2. Resting heart rate &gt; 100 bpm;&#xD;
&#xD;
               3. Stage IV or V chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR)&#xD;
                  that remains &lt; 30 mL/min/1.73m2 by MDRD) or nonresponsive to diuretic therapy or&#xD;
                  on chronic renal dialysis;&#xD;
&#xD;
          7. Severe pulmonary hypertension with systolic pulmonary artery pressure ≥80 mmHg;&#xD;
&#xD;
          8. Pulmonary hypertension other than group II PH;&#xD;
&#xD;
          9. Anemia requiring transfusions, iron infusions, or hemoglobin below 100;&#xD;
&#xD;
         10. Coagulopathy or uninterruptible anticoagulation therapy or contraindication to&#xD;
             antiplatelet/anticoagulant treatments anticipated in the protocol;&#xD;
&#xD;
         11. Intolerance to aspirin or clopidogrel;&#xD;
&#xD;
         12. Active infection requiring systemic antibiotics;&#xD;
&#xD;
         13. Unwillingness to sign informed consent or to attend the outpatient clinic;&#xD;
&#xD;
         14. Participation in another research trial with intervention;&#xD;
&#xD;
         15. Discharge to a chronic care facility or residence in an outlying area;&#xD;
&#xD;
         16. Pregnant or lactating women or women of childbearing potential who are not protected&#xD;
             from pregnancy by an accepted method of contraception, such as the oral contraceptive&#xD;
             pill, an intrauterine device or surgical sterilization. If necessary a negative urine&#xD;
             or blood test will be performed before randomization&#xD;
&#xD;
         17. Any condition that in the opinion of the investigator would jeopardize the evaluation&#xD;
             for efficacy or safety or be associated with poor adherence to the protocol, including&#xD;
             cognitive decline.&#xD;
&#xD;
         18. Life expectancy &lt;1 year;&#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>Anique Ducharme</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Rouleau, MD</last_name>
    <role>Study Director</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anique Ducharme, MD</last_name>
    <phone>5143763330</phone>
    <phone_ext>3947</phone_ext>
    <email>anique.ducharme@umontreal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hélène Brown, BSc CCRP</last_name>
    <phone>5143763330</phone>
    <phone_ext>3931</phone_ext>
    <email>helene.brown@icm-mhi.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hélène Brown, RN, B.Sc</last_name>
      <phone>514-376-3330</phone>
      <phone_ext>3931</phone_ext>
      <email>helene.brown@icm-mhi.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Henri, MD</last_name>
      <phone>514-376-3330</phone>
      <phone_ext>3947</phone_ext>
      <email>henri_christine@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Helene Brown, RN. B.Sc.</last_name>
      <phone>514-376-3330</phone>
      <phone_ext>3931</phone_ext>
      <email>helene.brown@icm-mhi.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montreal Heart Institute</investigator_affiliation>
    <investigator_full_name>Anique Ducharme</investigator_full_name>
    <investigator_title>MD, MSc. Director of the Heart Failure clinic</investigator_title>
  </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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT04441203/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04441203
org study id: MHICC-2018-001
nct id: NCT04441203
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management
      using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to
      decreased: hospital admissions for heart failure (HF), emergency department consultation
      and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a
      regular HFC, has low device-related complications and is cost-effective, in New York Heart
      Association (NYHA) class III and II (requiring diuretics) patients.
This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE)
      trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed
      using remote access to hemodynamics compared to a non-implanted control group. Patients with
      at least one hospitalization for HF (≥1) in the previous year (12 months) will be randomized
      into two groups, regardless of LVEF:

      Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or
      Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse
      clinician and patient empowerment with access to the PAP data (CardioMEMS group).

      Primary and secondary endpoints will be compared between groups after 12 months of follow-up
      and within groups comparing baseline parameters with 12 month follow-up measurements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.
primary purpose: Treatment
masking: None (Open Label)
measure: first occurrence of any component of the composite event
time frame: 12 months
description: acute decompensated heart failure requiring emergency department consultation
measure: Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
time frame: 12 months
description: unplanned intravenous heart failure therapy in an outpatient clinic
measure: Number of Participants with hospital admission for heart failure
time frame: 12 months
description: hospital admission for heart failure
measure: Number of Participants with cardiovascular (CV) death
time frame: 12 months
description: cardiovascular (CV) death
measure: Time to the first occurrence of the individual components of the primary endpoint
time frame: 12 months
description: Acute decompensated heart failure that requires emergency department consultation and/or unplanned intravenous heart failure therapy in an outpatient clinic
measure: Number of Participants with CV death
time frame: 12 months
description: CV death
measure: Change in Quality of life
time frame: 12 months
description: Quality of life questionnaire
measure: Change in functional capacity between baseline and 12-months
time frame: 12 months
description: NYHA functional class (Kansas city cardiomyopathy questionnaire)
measure: Change in 6 minutes walk distance
time frame: 12 months
description: 6 minutes walk distance test
measure: Number of Participants with device-related endpoints
time frame: 12 months
description: Safety: adverse events related to the device
measure: Number of successful patient contacts
time frame: 12 months
description: Number of successful patient contacts
measure: Pulmonary artery pressures changes mesured by the CardioMems device
time frame: 12 months
description: Pulmonary artery pressures changes mesured by the CardioMems device
measure: Cost-effectiveness
time frame: 12 months
description: cost-effectiveness ratio
arm group label: Control
arm group type: No Intervention
description: Heart failure clinic follow up
arm group label: CardioMems
arm group type: Active Comparator
description: The treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.
intervention type: Device
intervention name: CardioMems
description: novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System
arm group label: CardioMems
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anique Ducharme
role: Principal Investigator
affiliation: Montreal Heart Institute
last name: Jean Rouleau, MD
role: Study Director
affiliation: Montreal Heart Institute
last name: Anique Ducharme, MD
phone: 5143763330
phone ext: 3947
email: anique.ducharme@umontreal.ca
last name: Hélène Brown, BSc CCRP
phone: 5143763330
phone ext: 3931
email: helene.brown@icm-mhi.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Montreal Heart Institute
investigator full name: Anique Ducharme
investigator title: MD, MSc. Director of the Heart Failure clinic
mesh term: Heart Failure
sharing ipd: No
provided document: 