Clinical Evaluation of Cordio App in Adult ADHF Patients

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266029
• Other study ID #: CA001
• Status: Completed
• Start date: May 24, 2015
• Est. completion date: December 10, 2020

Study information

• Verified date: February 2021
• Source: Cordio Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 10, 2020
• Est. primary completion date: August 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Cordio App

Locations

Country	Name	City	State
Israel	Rambam Health Care Facility	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)	Anyalysis of voice recordings; admission vs. discharge	5 years