Remote Speech Analysis in HF Patients Undergoing Haemodialysis

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714126
• Other study ID #: CLN0014
• Status: Completed
• Start date: March 27, 2019
• Est. completion date: March 8, 2021

Study information

• Verified date: April 2020
• Source: Cordio Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cordio Medical
Recording to an app, no interference to the regular care

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Country where clinical trial is conducted

Israel, 

Outcome

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