Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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.

More Heart Failure trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment850 (estimated)
SponsorCardioStory INC
Industry-sponsored
Locations2 sites (Monastir, Monastir Governorate and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedOctober 2, 2026
Trial IDNCT07685106 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.