Clinical Evaluation of Cordio App in Adult ADHF Patients

Cordio Medical

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: Cordio App

Study type: Observational

Funder types: Industry

Identifiers

NCT03266029

CA001

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.