DyspneaCARDIOSTORYNCT07147699
Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea
An observational study of Dyspnea and Heart Failure Acute, run by Hôpital Universitaire Sahloul.
Trial summary
The CARDIOSTORY.TN study is a prospective observational study at Sahloul University Hospital (Sousse, Tunisia) evaluating the CardioStory device for distinguishing heart failure (HF) from other causes of acute dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Heart Failure Acute
- What is being tested?
- cardiostory
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: every patient consulting with 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
About this study
The CARDIOSTORY.TN study is a prospective observational study at Sahloul University Hospital (Sousse, Tunisia) evaluating the CardioStory device for distinguishing heart failure (HF) from other causes of acute dyspnea.
Background: Dyspnea is common in emergencies, and differentiating cardiac from non-cardiac causes is often delayed by the limits of echocardiography and BNP tests. CardioStory is a rapid (~2 minutes), non-invasive tool that measures cardiac filling pressure, a key HF marker.
Read more
Objectives:
Primary: Assess CardioStory's diagnostic accuracy.
Secondary: Compare it with echocardiography and NT-proBNP, evaluate ease of use, and measure time to diagnosis.
Methods:
Adults (≥18) with acute dyspnea (<7 days) included; unstable or traumatic/allergic cases excluded.
CardioStory results will be compared to standard diagnostics.
Sample size: 850 patients over 12 months.
Outcome: If accurate, CardioStory could be a fast, practical diagnostic tool for emergency settings.
- Conditions
- Dyspnea, Heart Failure Acute
- Being tested
- cardiostory
- Keywords
- dyspnea, acute heart failure
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiostoryDevice
measure the pressure of remplissage
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
Measured: 12 hours
Secondary outcomes (1)
o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: This record was withdrawn prior to enrollment. The study was subsequently re-registered under the sponsor's Responsible Party as NCT07685106, which reflects the transfer of study conduct from the investigator-initiated phase to the sponsoring compan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147699
- Sponsor's protocol ID
- CARDIOSTORY
- Acronym
- CARDIOSTORY
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 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
- NCT07147699
- Acronym / sponsor ID
- CARDIOSTORY / CARDIOSTORY
- Conditions
- Dyspnea, Heart Failure Acute
- Keywords
- dyspnea, acute heart failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This record was withdrawn prior to enrollment. The study was subsequently re-registered under the sponsor's Responsible Party as NCT07685106, which reflects the transfer of study conduct from the investigator-initiated phase to the sponsoring compan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Aug 2025 (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.
The CARDIOSTORY.TN study is a prospective observational study at Sahloul University Hospital (Sousse, Tunisia) evaluating the CardioStory device for distinguishing heart failure (HF) from other causes of acute dyspnea.
Background: Dyspnea is common in emergencies, and differentiating cardiac from non-cardiac causes is often delayed by the limits of echocardiography and BNP tests. CardioStory is a rapid (~2 minutes), non-invasive tool that measures cardiac filling pressure, a key HF marker.
Objectives:
Primary: Assess CardioStory's diagnostic accuracy.
Secondary: Compare it with echocardiography and NT-proBNP, evaluate ease of use, and measure time to diagnosis.
Methods:
Adults (≥18) with acute dyspnea (<7 days) included; unstable or traumatic/allergic cases excluded.
CardioStory results will be compared to standard diagnostics.
Sample size: 850 patients over 12 months.
Outcome: If accurate, CardioStory could be a fast, practical diagnostic tool for emergency settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient consulting with dyspnea
Key inclusion criteria (3 listed)
- • Age ≥ 18 years
Key exclusion criteria (3 listed)
- • Age inferior to 18 years,
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 |
|---|---|---|
| cardiostorymeasure the pressure of remplissage | Device | – |
Primary outcome
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
Time frame: 12 hours
1 secondary outcome
o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)
Time frame: 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Heart Failure Acute, run by Hôpital Universitaire Sahloul.
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: withdrawn, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV). (time frame: 12 hours). 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 30 Sep 2026.