2-Minute heart scan could transform emergency diagnosis of heart failure

NCT ID NCT07685106

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial evaluates a new device called CardioStory that uses fiber-optic sensors to measure heart filling pressure in about two minutes—without needles or catheters. Researchers are enrolling 850 adults who come to the emergency department with recent shortness of breath. The goal is to see if the device can accurately distinguish heart failure from other causes like lung problems, helping doctors make faster, more informed decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CardioStory device (non-invasive cardiac assessment device)
What this could lead to
If successful, this device could help emergency doctors quickly tell whether shortness of breath is due to heart failure or another cause, without invasive procedures.
What could go wrong
The device is still being tested and may not prove accurate enough to replace standard diagnostic methods. Results may vary across different patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients presenting to the emergency department with acute or subacute dyspnea without an established diagnosis. This population represents patients requiring urgent evaluation to differentiate between cardiac and non-cardiac causes of dyspnea.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fattouma bourguiba university hospital

    RECRUITING

    Monastir, Monastir Governorate, 5000, Tunisia

  • Sahloul university hospital

    RECRUITING

    Sousse, 4054, Tunisia

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