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Clinical Evaluation of Cordio App in Adult ADHF Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266029
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Cordio Medical

Brief Summary:
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.

Condition or disease Intervention/treatment
Congestive Heart Failure Device: Cordio App

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF
Actual Study Start Date : May 24, 2015
Actual Primary Completion Date : August 2020
Actual Study Completion Date : December 10, 2020



Primary Outcome Measures :
  1. 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 ]
    Anyalysis of voice recordings; admission vs. discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hospitals/ CHF clinics
Criteria

Inclusion Criteria:

  • Diagnosis of ADHF (pulmonary congestion)
  • Known diagnosis of HF, with either preserved or reduced LVEF.
  • 18+ years old.
  • Able to understand and provide written informed consent.

Exclusion Criteria:

  • Subjects unable to comply with the daily use of the application due to mental disorders.
  • GFR <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
  • Subjects with congenital heart disease or mechanical right heart valve(s).
  • Airway and lung infection and Sepsis
  • Patients with severe alcohol or drug use.
  • Women who are pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266029


Locations
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Israel
Rambam Health Care Facility
Haifa, Israel
Sponsors and Collaborators
Cordio Medical
Investigators
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Principal Investigator: Zaher Azzam, Prof. Rambam Health Care Facility
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cordio Medical
ClinicalTrials.gov Identifier: NCT03266029    
Other Study ID Numbers: CA001
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases