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NOT YET RECRUITING
NCT07147699

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

Sponsor: Hôpital Universitaire Sahloul

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

650

Start Date

2025-09-01

Completion Date

2026-12-01

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DEVICE

cardiostory

measure the pressure of remplissage