Remote Speech Analysis in HF Patients Undergoing Haemodialysis

Completed

• Conditions: Heart Failure

• Registration Number: NCT03714126
• Lead Sponsor: Cordio Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2019-03-27
• Status Verified: 2020-04
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel