NCT07147699Withdrawn
Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Reason given: This record was withdrawn prior to enrollment. The study was subsequently re-registered under the sponsor's Responsible Party as NCT07685106, which reflects the transfer of study conduct from the investigator-initiated phase to the sponsoring compan
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Observational
- Enrollment
- 0 (actual)
- First submitted
- 22 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Hôpital Universitaire Sahloul
- Diseases
- Heart failure
- NCT number
- NCT07147699
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- • 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
Who the study is looking for
- • Age ≥ 18 years
- Recent onset dyspnea (less than 7 days)
- Informed consent obtained
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.