NCT07147699

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Hôpital Universitaire Sahloul · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspnea
• Heart Failure Acute

Interventions

Type	Name	Description
DEVICE	cardiostory	measure the pressure of remplissage

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-08-29
• Last updated: 2025-08-29