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Completed

NCT Number: NCT03714126

Remote Speech Analysis in HF Patients Undergoing Haemodialysis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Center

Jerusalem, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cordio Medical

Device

Recording to an app, no interference to the regular care

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cordio Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2018
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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