CardioStory device in helping tell heart failure from other causes in people with shortness of breath
Official title: Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
Run by CardioStory INC · NCT07685106 · Data updated 2026-11-12
This study tests whether the CardioStory noninvasive device can help emergency department clinicians distinguish heart failure from other causes of dyspnea in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 850 (estimated) |
| Sponsor | CardioStory INC Industry-sponsored |
| Locations | 2 sites (Monastir, Monastir Governorate and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07685106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older presenting with recent-onset dyspnea (within 7 days) who can provide informed consent and do not have severe comorbidity, hemodynamic instability, immediate need for ventilation, or dyspnea from trauma or allergy.
✕Probably not a fit
Patients with traumatic or allergic dyspnea, severe instability, or those requiring immediate mechanical ventilation may not benefit from the device in this setting.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study enrolled adults presenting to the emergency department with new or worsening dyspnea. Data were collected from standard clinical care, including medical history, physical examination, labs, and echocardiography, plus noninvasive cardiovascular measurements from the CardioStory device. The goal is to see if CardioStory measurements can improve identification of heart failure versus non-cardiac causes of dyspnea. No intervention beyond routine assessment and CardioStory measurements is performed. Results will inform the device’s potential role in acute care decision-making.
Why it matters
Potential benefit: If successful, CardioStory could help clinicians quickly and more accurately identify heart failure in patients with dyspnea, potentially guiding treatment decisions.
How similar studies have gone: Previous research has explored noninvasive cardiac assessments for dyspnea, with mixed results; this study adds prospective real-world data in the ED using CardioStory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Recent onset dyspnea (less than 7 days) * Informed consent obtained Exclusion Criteria: * 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
Where it's running
-
Fattouma bourguiba university hospital
Monastir, Monastir Governorate, Tunisia Recruiting -
Sahloul university hospital
Sousse, Tunisia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.