Clinical Trial

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

Study acronym: CARDIOSTORY
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07147699
Lead Sponsor Hôpital Universitaire Sahloul
Conditions Dyspnea, Heart Failure Acute
Enrollment 650 participants
Start Date 2025-09-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-29