An observational study in Dyspnea and Heart Failure Acute, sponsored by Hôpital Universitaire Sahloul. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Hôpital Universitaire Sahloul · Observational
This record was withdrawn prior to enrollment.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
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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.
894 studies on the registry are indexed under Dyspnea; 188 are open to participants now.
Browse Dyspnea studies →Hôpital Universitaire Sahloul is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
every patient consulting with 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.
Age ≥ 18 years
Exclusion Criteria:
Age inferior to 18 years,
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.
measure the pressure of remplissage
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
Time frame: 12 hours
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
No study locations are listed for this record.
Start is estimated for Sep 2025; primary completion for Nov 2026, 14 months later.
How these figures are worked out, and which studies are left out of them.
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
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
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 withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hôpital Universitaire Sahloul