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NCT Number: NCT07147699

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

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.

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Key information

Conditions

Dyspnea Heart Failure Acute Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiostory

Device

measure the pressure of remplissage

Primary outcomes

  1. Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).

    Time frame: 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)

    Time frame: 12 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Rahma Jaballah, Professor

CONTACT

[email protected]

+21655600033

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Sahloul

Other

Registry information

Acronym: CARDIOSTORY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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