Remote Speech Analysis in HF Patients Undergoing Haemodialysis

A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03714126

Enrollment

Registered

2018-10-22

Start date

2019-03-27

Completion date

2021-03-08

Last updated

2021-03-09

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

Conditions

Heart Failure

Brief summary

This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

Interventions

DEVICECordio Medical

Recording to an app, no interference to the regular care

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload. * Class C Heart Failure patient with reduced EF CHF (EF\<40%) and NYHA 2-3. * Patients with dyspnea clinically related to pulmonary congestion * Patient with more than 3 months HF disease duration. * The patient is willing to participate as evidenced by signing the written informed consent. * Male or non-pregnant female patient

Exclusion criteria

* Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia). * Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. * Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4. * Patients with evidence of active Infection. * Patient with severe alcohol or drug use. * Psychological instability, inappropriate attitude or motivation. * Patient with life threatening debilitating disease other than cardiac. * Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Design outcomes

Primary

Measure	Time frame	Description
Number of CHF patients with and without acute lung accumulation. in R&D Database	throughout study, upto 60 days per patient	The objective of the study is to create a recordings database of CHF patients with and without acute lung accumulation.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026