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

Not yet recruiting

• Conditions: Dyspnea; Heart Failure Acute

• Registration Number: NCT07147699
• Lead Sponsor: Hôpital Universitaire Sahloul

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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