An observational study in Heart Failure and Dyspnea, sponsored by CardioStory INC. Recruiting at 2 sites in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by CardioStory INC · Observational
This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical history, physical examination, laboratory tests, and echocardiography results, as well as non-invasive cardiovascular measurements obtained using the CardioStory device.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 850 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with CardioStory INC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the emergency department with acute or subacute dyspnea without an established diagnosis. This population represents patients requiring urgent evaluation to differentiate between cardiac and non-cardiac causes of dyspnea.
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.
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.
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.
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.
Adult patients presenting to the emergency department with acute dyspnea.
Device: Non invasive cardiac assessment with the CardioStory device
The CardioStory device, is a non-invasive medical technology designed to rapidly (approximately 2 minutes) assess cardiac filling pressure in patients with suspected or established heart failure. It uses proprietary fiber-optic sensors combined with advanced signal processing and analytical algorithms to detect and analyze physiological signals related to cardiac mechanical function. These signals are processed to generate a quantitative estimate of cardiac filling pressure without the need for catheterization, contrast agents, or injectable substances. The measurement is performed non-invasively and is designed to be simple, rapid, and reproducible.
Diagnostic performance assessment of the CardioStory device.
To assess the diagnostic performance of the CardioStory device in differentiating patients with heart failure from those with non-cardiac causes of dyspnea (including respiratory, metabolic etiologies) in patients presenting to the emergency department, using standard clinical assessments as the reference standard.
Time frame: Day 1
To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.
Time frame: Day 1
To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools
Evaluating the correlation between CardioStory-derived cardiac filling pressures and NT-proBNP levels, as well as the correlation between CardioStory measurements and echocardiography-derived parameters of cardiac function
Time frame: Day 1
To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.
Time (in minutes) from initiation of the CardioStory measurement to availability of the diagnostic result, compared with the time required for standard clinical assessments.
Time frame: Day 1
To assess the adverse event occurrences of the CardioStory device in the emergency setting.
Safety data will be collected for all participants. Any adverses event occurring within 30 min to 24 hours after the use of the CardioStory device will be documented and recorded
Time frame: Day 1
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 ↗
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