An observational study in Chronic Heart Failure, sponsored by Cordio Medical. Completed at 8 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Cordio Medical · Observational
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.
Among the 2,156 studies in Heart Failure with a site in United States, this one is the 234th 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 1,789th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 216 is close to the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →348 of the 2,156 studies in Heart Failure with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
The full table on the hub →2,156 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 107 started in 2022.
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.
745 of 2,156 have an industry lead sponsor. The 10 most frequent:
Cordio Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.
Cordio Medical has 5 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
139 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Among the 2,156 studies in Heart Failure with a site in United States, from their registry updates:
To determine the usability and technical aspects of Cordio HearO™
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
Adult clinical stable patients with NYHA II-IVa (ambulatory)
Major inclusion Criteria:
At least one of the following:
Major exclusion Criteria:
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
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 (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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction. Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome
Time frame: 2 years
Patient Usability success defined as: 2. Total Compliance
The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
Time frame: 2 Years
Ran from Mar 2022 to primary completion in Nov 2024, 32 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Jan 2025 → Nov 2024 and completion Mar 2025 → Nov 2024.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Cordio Medical