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CompletedNCT03714126Updated Mar 9, 2021

Remote Speech Analysis in HF Patients Undergoing Haemodialysis

An observational study in Heart Failure, sponsored by Cordio Medical. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Cordio Medical · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
6
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Heart Failure

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
6 participants (actual)
Patient registry
No

Groups and cohorts

  • HF patients

    HF patients will use the Cordio Medical app to record in their hospital visits and at home.

    Device: Cordio Medical

Interventions

  • DeviceCordio Medical

    Recording to an app, no interference to the regular care

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: throughout study, upto 60 days per patient

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Study locations

1 site
  • Hadassah Medical Center
    Jerusalem, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03714126
Lead sponsor
Cordio Medical
Responsible party
Sponsor
First posted
Oct 22, 2018
Start date
Mar 27, 2019
Primary completion
Mar 8, 2021
Completion
Mar 8, 2021
Last update
Mar 9, 2021

Study contacts

Ittamar Gork, Dr.
principal investigator · Hadassah Ein Kerem

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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