Remote Speech Analysis in HF Patients Undergoing Haemodialysis

March 8, 2021 updated by: Cordio Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute and Chronic Congestive Heart Failure patients, undergoing hemodialysis in order to balance their volume overload.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HF patients
HF patients will use the Cordio Medical app to record in their hospital visits and at home.
Device: Cordio Medical
Recording to an app, no interference to the regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CHF patients with and without acute lung accumulation. in R&D Database
Time Frame: 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.
throughout study, upto 60 days per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordio Medical

Investigators

  • Principal Investigator: Ittamar Gork, Dr., Hadassah Ein Kerem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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