<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/NCT03266029</url>
  </required_header>
  <id_info>
    <org_study_id>CA001</org_study_id>
    <nct_id>NCT03266029</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Cordio App in Adult ADHF Patients</brief_title>
  <official_title>Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cordio Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cordio Medical</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>
      Observational study on ADHF patients at one site in Israel. After signing informed consent&#xD;
      and undergoing screening assessments, eligible patients will record sentences into a&#xD;
      smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The&#xD;
      patient will record at hospital: admittion, release. Before hospital release, if applicable&#xD;
      and upon patient agrreement, an app will be installed in a smartphone in order to continue&#xD;
      the recording at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2015</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 2020</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>voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)</measure>
    <time_frame>5 years</time_frame>
    <description>Anyalysis of voice recordings; admission vs. discharge</description>
  </primary_outcome>
  <enrollment type="Actual">89</enrollment>
  <condition>Congestive Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cordio App</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitals/ CHF clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of ADHF (pulmonary congestion)&#xD;
&#xD;
          -  Known diagnosis of HF, with either preserved or reduced LVEF.&#xD;
&#xD;
          -  18+ years old.&#xD;
&#xD;
          -  Able to understand and provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable to comply with the daily use of the application due to mental&#xD;
             disorders.&#xD;
&#xD;
          -  GFR &lt;25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal&#xD;
             dialysis.&#xD;
&#xD;
          -  Subjects with congenital heart disease or mechanical right heart valve(s).&#xD;
&#xD;
          -  Airway and lung infection and Sepsis&#xD;
&#xD;
          -  Patients with severe alcohol or drug use.&#xD;
&#xD;
          -  Women who are pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Zaher Azzam, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Facility</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Facility</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</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>
  </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/NCT03266029
org study id: CA001
nct id: NCT03266029
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study on ADHF patients at one site in Israel. After signing informed consent
      and undergoing screening assessments, eligible patients will record sentences into a
      smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The
      patient will record at hospital: admittion, release. Before hospital release, if applicable
      and upon patient agrreement, an app will be installed in a smartphone in order to continue
      the recording at home.
observational model: Cohort
time perspective: Prospective
measure: voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)
time frame: 5 years
description: Anyalysis of voice recordings; admission vs. discharge
intervention type: Device
intervention name: Cordio App
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Zaher Azzam, Prof.
role: Principal Investigator
affiliation: Rambam Health Care Facility
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No