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OpenTrials
Completed

NCT Number: NCT03266029

Clinical Evaluation of Cordio App in Adult ADHF Patients

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Facility

Haifa, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cordio App

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cordio Medical

Industry

Registry information

Official study title

Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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