Heart FailureCARDIOSTORY TNNCT07685106
Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
An observational study of Heart Failure and Dyspnea, run by CardioStory INC at 2 sites in Tunisia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Dyspnea
- What is being tested?
- Non invasive cardiac assessment with the CardioStory device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 850 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- Recent onset dyspnea (less than 7 days)
- Informed consent obtained
Who cannot join
- Age inferior to 18 years,
- Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were exclusion criteria.
- Dyspnea clearly of traumatic or allergic origin
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia2 sites, 2 recruiting
- Recruiting
Fattouma bourguiba university hospital
Monastir, Monastir Governorate, 5000
Samir Nouira, Professor, +21673106046, semir.nouira.urg@gmail.com
Houda Chaouch, PhD, +21697453468, chawech_houda@yahoo.fr
- Recruiting
Sahloul university hospital
Sousse, 4054
Riadh Boukef, Professor, +21698676745, riadboukef@gmail.com
Houda Chaouch, PhD, 97453468, chawech_houda@yahoo.fr
About this study
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.
- Conditions
- Heart Failure, Dyspnea
- Being tested
- Non invasive cardiac assessment with the CardioStory device
- Keywords
- dyspnea, Heart failure, non-cardiac causes of dyspnea, cardiostory, cardiac assessment device, cardiac causes of dyspnea
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive cardiac assessment with the CardioStory deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from Dyspnea | Adult patients presenting to the emergency department with acute dyspnea. Receives: Device: Non invasive cardiac assessment with the CardioStory device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.
Measured: 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
Measured: 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.
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioStory INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eshmoun Clinical Research Center, Sahloul Hospital of Sousse, University Hospital Monastir, Tunis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685106
- Sponsor's protocol ID
- CS-HF_DYSP-2025
- Acronym
- CARDIOSTORY TN
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
- ClinicalTrials.gov ID
- NCT07685106
- Acronym / sponsor ID
- CARDIOSTORY TN / CS-HF_DYSP-2025
- Conditions
- Heart Failure, Dyspnea
- Keywords
- dyspnea, Heart failure, non-cardiac causes of dyspnea, cardiostory, cardiac assessment device, cardiac causes of dyspnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- CardioStory INCIndustry (pharma, biotech, devices)
- Collaborators
- Eshmoun Clinical Research Center, Sahloul Hospital of Sousse, University Hospital Monastir, Tunis
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from Dyspnea | – | Device: Non invasive cardiac assessment with the CardioStory deviceAdult patients presenting to the emergency department with acute dyspnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Recent onset dyspnea (less than 7 days)
- Informed consent obtained
Key exclusion criteria (3 listed)
- Age inferior to 18 years,
- Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were exclusion criteria.
- Dyspnea clearly of traumatic or allergic origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive cardiac assessment with the CardioStory deviceThe 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. | Device | Patients suffering from Dyspnea |
Primary outcome
Diagnostic performance assessment of the CardioStory device.
Time frame: Day 1
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.
4 secondary outcomes
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
Time frame: Day 1
To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.
Time frame: Day 1
To assess the adverse event occurrences of the CardioStory device in the emergency setting.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Dyspnea, run by CardioStory INC at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance assessment of the CardioStory device. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.