<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/NCT04444583</url>
  </required_header>
  <id_info>
    <org_study_id>REFLECS-FI</org_study_id>
    <nct_id>NCT04444583</nct_id>
  </id_info>
  <brief_title>Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI</brief_title>
  <acronym>REFLECS-FI</acronym>
  <official_title>Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Precordior Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Precordior Ltd</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>
      In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify&#xD;
      patients with heart failure will be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood&#xD;
      in circulation corresponding to prevailing physiological demand. Gyrocardiography is a&#xD;
      technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope,&#xD;
      to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of&#xD;
      this study is to test the ability of an app of a smartphone with embedded motion sensors,&#xD;
      positioned on the chest which measures the movements and function of the heart, to identify&#xD;
      patients with different types of heart failure and their characteristics, as compared with&#xD;
      clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac&#xD;
      mechanics including strain, cardiac torsion, diastolic filling characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HF specific motion sensor characteristics validation against echocardiography and other clinical features</measure>
    <time_frame>From the hospital admission to study closure visit, on average 15 weeks</time_frame>
    <description>The study aims to validate HF specific characteristics obtained with accelerometer (m/s2) and gyroscope (degree/s) against the current gold standard, detailed echocardiography examination in individuals already diagnosed with HF. Data of anonymised subjects without diagnosed or suspected HF will be used as controls to study the detection of HF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HF decompensation specific motion sensor characteristics validation</measure>
    <time_frame>14 weeks</time_frame>
    <description>The ability of the motion sensors to detect differences in myocardial mechanics in patients with decompensation episode compared to patients without decompensation episode, assessed by receiver operating characteristics (ROC).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">155</enrollment>
  <condition>Heart Failure</condition>
  <condition>Heart Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>HFpEF</arm_group_label>
    <description>HF patients with preserved ejection fraction (HFpEF)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFrEF</arm_group_label>
    <description>HF patients with reduced ejection fraction (HFrEF)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at&#xD;
        Helsinki University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Patients visiting hospital for heart failure, either outpatient clinic or cardiac ward&#xD;
&#xD;
          -  Signed informed consent as an acceptance to participate to the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
               -  Severe cardiac valve disease&#xD;
&#xD;
               -  Previous prosthetic cardiac valve&#xD;
&#xD;
               -  Major adverse cardiovascular event or surgery within 6 weeks of planned study&#xD;
                  enrollment&#xD;
&#xD;
               -  Patients with pacemaker&#xD;
&#xD;
               -  Informed consent form not signed.&#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>Antti Saraste, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Center Turku University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart and Lung Center at Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center at Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Heart Failure</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</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/NCT04444583
org study id: REFLECS-FI
nct id: NCT04444583
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify
      patients with heart failure will be studied.
Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood
      in circulation corresponding to prevailing physiological demand. Gyrocardiography is a
      technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope,
      to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of
      this study is to test the ability of an app of a smartphone with embedded motion sensors,
      positioned on the chest which measures the movements and function of the heart, to identify
      patients with different types of heart failure and their characteristics, as compared with
      clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac
      mechanics including strain, cardiac torsion, diastolic filling characteristics.
observational model: Cohort
time perspective: Prospective
measure: HF specific motion sensor characteristics validation against echocardiography and other clinical features
time frame: From the hospital admission to study closure visit, on average 15 weeks
description: The study aims to validate HF specific characteristics obtained with accelerometer (m/s2) and gyroscope (degree/s) against the current gold standard, detailed echocardiography examination in individuals already diagnosed with HF. Data of anonymised subjects without diagnosed or suspected HF will be used as controls to study the detection of HF.
measure: HF decompensation specific motion sensor characteristics validation
time frame: 14 weeks
description: The ability of the motion sensors to detect differences in myocardial mechanics in patients with decompensation episode compared to patients without decompensation episode, assessed by receiver operating characteristics (ROC).
arm group label: HFpEF
description: HF patients with preserved ejection fraction (HFpEF)
arm group label: HFrEF
description: HF patients with reduced ejection fraction (HFrEF)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antti Saraste, MD, PhD
role: Principal Investigator
affiliation: Heart Center Turku University Hospital
facility: 
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiovascular Diseases
mesh term: Heart Diseases
sharing ipd: No