ClinicalTrials.gg
CompletedNCT03266029Updated Mar 5, 2021

Clinical Evaluation of Cordio App in Adult ADHF Patients

An observational study in Congestive 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 2021-03-05.

Sponsored by Cordio Medical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
89
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
30th of 46
89 · median 150
Started
2015
with 9 others
Observational
46 of 182
7 open now
Registered
124th 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 30th largest by enrollment of the 46 observational ones, is one of 10 that started in 2015, is one of 46 observational ones, and was the 124th 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. 10 started in 2015.

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

Observational study on ADHF patients at one site in Israel. After signing informed consent and undergoing screening assessments, eligible patients will record sentences into a smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital: admittion, release. Before hospital release, if applicable and upon patient agrreement, an app will be installed in a smartphone in order to continue the recording at home.

03

Conditions studied

  • Congestive Heart Failure

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04

Who can participate

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

Study population

Hospitals/ CHF clinics

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

  • Diagnosis of ADHF (pulmonary congestion)
  • Known diagnosis of HF, with either preserved or reduced .
  • 18+ years old.
  • Able to understand and provide written .

Exclusion criteria

Exclusion Criteria:

  • Subjects unable to comply with the daily use of the application due to mental disorders.
  • \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
  • Subjects with congenital heart disease or mechanical right heart valve(s).
  • Airway and lung infection and Sepsis
  • Patients with severe alcohol or drug use.
  • Women who are pregnant or lactating.
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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
89 participants (actual)
Patient registry
No

Interventions

  • DeviceCordio App
06

What researchers measure

Primary outcomes

  1. voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)

    Anyalysis of voice recordings; admission vs. discharge

    Time frame: 5 years

07

Study locations

1 site
  • Rambam Health Care Facility
    Haifa, Israel
08

References and documents

Publications

  • Amir O, Abraham WT, Azzam ZS, Berger G, Anker SD, Pinney SP, Burkhoff D, Shallom ID, Lotan C, Edelman ER. Remote Speech Analysis in the Evaluation of Hospitalized Patients With Acute Decompensated Heart Failure. JACC Heart Fail. 2022 Jan;10(1):41-49. doi: 10.1016/j.jchf.2021.08.008. Epub 2021 Dec 8. PubMed 34969496 ↗

Individual participant data

Plan to share: No

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 May 2015 to primary completion in Aug 2020, 63 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 63 months is above 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
Aug 19, 2017
First posted
Aug 29, 2017
StartActual
May 24, 2015
Primary completionActual
Aug 2020
CompletionActual
Dec 10, 2020
Last update
Mar 5, 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 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03266029
Lead sponsor
Cordio Medical
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
May 24, 2015
Primary completion
Aug 2020
Completion
Dec 10, 2020
Last update
Mar 5, 2021

Study contacts

Zaher Azzam, Prof.
principal investigator · Rambam Health Care Facility

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 Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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