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

NCT07147699 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

DEVICE

cardiostory

measure the pressure of remplissage

Sponsors & Collaborators

  • Hôpital Universitaire Sahloul

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-11-01
Completion
2026-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147699 on ClinicalTrials.gov