ClinicalTrials.gg
CompletedNCT06378632DETECT-HFUpdated Nov 6, 2026

AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

An observational study in Heart Failure, sponsored by Cordio Medical. Completed at 45 sites in 3 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Cordio Medical · Observational

Updated Nov 6, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
563
Ages
22 Years and older
Sex
All
01

Where this study stands

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

Among 2,156 studies in Heart Failure with a site in United States — 348 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.

Enrollment
156th of 551
563 · median 150
Started
2022
with 106 others
Observational
552 of 2,156
103 open now
Registered
1,911th of 2,156
by date

Among the 2,156 studies in Heart Failure with a site in United States, this one is the 156th largest by enrollment of the 551 observational ones, is one of 107 that started in 2022, is one of 552 observational ones, and was the 1,911th registered.

By phase

2,156 studies; the count open now beside each. This study's row is marked.

No phase886 · 161 open
Observationalthis study552 · 103 open
Phase 2226 · 24 open
Phase 3147 · 21 open
Phase 4139 · 13 open
Phase 1118 · 18 open
Phase 1/256 · 5 open
Phase 2/330 · 3 open
Other kind2 · 0 open

By the year they started

First in 1983; this study’s year is marked. 107 started in 2022.

Size and results

Median enrollment 65 across the 1,600 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,156 studies in Heart Failure with a site in United States, or all of them as a file.
02

Study summary

Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Read the detailed description

Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

03

Conditions studied

  • Heart Failure

Browse trials for

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatient clinics

Eligibility criteria

Major Inclusion Criteria:

  1. Age 22 or greater
  2. Diagnosed with Symptomatic Chronic Heart Failure [ II-IVa (ambulatory)]
  3. At least one of the following:

    1. One ADHF hospitalization in the last 12 months
    2. One unplanned IV/SC diuretic administration in the last 6 months
    3. Two unplanned IV/SC diuretic administrations in the last 12 months
    4. NTProBNP >500 pg/ml
  4. Clinically stable HF according to investigator discretion
  5. Willing to participate as evidenced by signing the written .

Major Exclusion Criteria:

  1. Unable to comply with daily use of the App,
  2. Has had a major cardiovascular event within 3 months prior to enrolment.
  3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  4. Has estimated (eGFR) \< 30 ml/min/1.73.
  5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
  6. Was treated for a significant
Terms in these criteria, in plain language(4)

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.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
563 participants (actual)
Patient registry
No

Interventions

  • DeviceHearo App

    No intervention - only data collection

06

What researchers measure

Primary outcomes

  1. Heart Failure Events (HFEs)

    Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period

    Time frame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient

07

Study locations

45 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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 Feb 2022 to primary completion in Aug 2025, 41 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 41 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.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Jul 2025 → Aug 2025 and completion Jul 2025 → Aug 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Apr 14, 2024
First posted
Apr 22, 2024
StartActual
Feb 11, 2022
Primary completionActual
Aug 3, 2025was Jul 2025
CompletionActual
Aug 3, 2025was Jul 2025
Last update
Nov 6, 2026
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.
Status
Recruiting→Completed
changed Nov 6, 2026
Sites
2 sites added, 2 sites removed
Show 2 added (1 United States, 1 Israel)
  • St. Johns Center for Clinical Research · Saint Augustine, United States
  • Assuta Be'er Sheva Medical Center · Beersheba, Israel
Show 2 removed
  • St. Johns Center for Clinical Research · St. Augustine, United States
  • Assuta Be'er Sheva Medical Center · Be'er Sheva, Israel
Nov 6, 2026
Primary completion
Jul 1, 2025→Aug 3, 2025 (actual)
Nov 6, 2026
Study completion
Jul 15, 2025→Aug 3, 2025 (actual)
Nov 6, 2026
Enrollment
500 (estimated)→563 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Completed
    2 sites added, 2 sites removed
    Show 2 added (1 United States, 1 Israel)
    • St. Johns Center for Clinical Research · Saint Augustine, United States
    • Assuta Be'er Sheva Medical Center · Beersheba, Israel
    Show 2 removed
    • St. Johns Center for Clinical Research · St. Augustine, United States
    • Assuta Be'er Sheva Medical Center · Be'er Sheva, Israel
    Primary completion Jul 1, 2025→Aug 3, 2025 (now actual)
    Study completion Jul 15, 2025→Aug 3, 2025 (now actual)
    Enrollment 500 (estimated)→563 (actual)
    + 4 other changes: oversight details, contact details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06378632
Lead sponsor
Cordio Medical
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Feb 11, 2022
Primary completion
Aug 3, 2025
Completion
Aug 3, 2025
Last update
Nov 6, 2026

Study contacts

Ronit Haviv, PhD
study director · Cordio Medical

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion