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

H

Hôpital Universitaire Sahloul

Status

Not yet enrolling

Conditions

Dyspnea
Heart Failure Acute

Treatments

Device: cardiostory

Study type

Observational

Funder types

Other

Identifiers

NCT07147699
CARDIOSTORY

Details and patient eligibility

About

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.

Enrollment

650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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 exclusion criteria.
    • Dyspnea clearly of traumatic or allergic origin

Trial contacts and locations

0

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Central trial contact

Rahma Jaballah, Professor

Data sourced from clinicaltrials.gov

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