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Clinical Evaluation of Cordio App in Adult ADHF Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03266029
Enrollment
89
Registered
2017-08-29
Start date
2015-05-24
Completion date
2020-12-10
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

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.

Interventions

Sponsors

Cordio Medical
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)5 yearsAnyalysis of voice recordings; admission vs. discharge

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026