ClinicalTrials.gg
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
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 182 studies in Heart Failure with a site in Israel — 23 open to participants now, 28 under way, 7 of them phase 3. Heart Failure · Israel.

Enrollment
45th of 46
6 · median 150
Started
2019
with 7 others
Observational
46 of 182
7 open now
Registered
134th of 182
by date
Lead sponsor
5 of 182
Cordio Medical

Among the 182 studies in Heart Failure with a site in Israel, this one is the 45th largest by enrollment of the 46 observational ones, is one of 8 that started in 2019, is one of 46 observational ones, and was the 134th registered.

By phase

182 studies; the count open now beside each. This study's row is marked.

No phase53 · 7 open
Observationalthis study46 · 7 open
Phase 339 · 7 open
Phase 225 · 1 open
Phase 410 · 1 open
Phase 2/34 · 0 open
Phase 13 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 1983; this study’s year is marked. 8 started in 2019.

Size and results

Median enrollment 260 across the 134 interventional studies, 150 across the 46 observational. Of the 116 that completed or were terminated, 43 (37%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 182 studies in Heart Failure with a site in Israel, or all of them as a file.
02

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.

03

Conditions studied

  • Heart Failure

Browse trials for

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 .
  • 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 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 device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

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

07

Study locations

1 site
  • Hadassah Medical Center
    Jerusalem, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Mar 2021, 23 months.

Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 23 months is below that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2018
First posted
Oct 22, 2018
StartActual
Mar 27, 2019
Primary completionActual
Mar 8, 2021
CompletionActual
Mar 8, 2021
Last update
Mar 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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