Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07147699

Acronym

CARDIOSTORY

Enrollment

650

Registered

2025-08-29

Start date

2025-09-01

Completion date

2026-12-01

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Heart Failure Acute

Keywords

dyspnea, acute heart failure

Brief 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. 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.

Interventions

DEVICEcardiostory

measure the pressure of remplissage

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* • Age ≥ 18 years * Recent onset dyspnea (less than 7 days) * Informed consent obtained

Exclusion criteria

* • Age inferior to 18 years, * Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).	12 hours

Secondary

Measure	Time frame
o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)	12 hours

Contacts

Primary ContactRahma Jaballah, Professor

jaballahrahma27@gmail.com+21655600033

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026