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AI eye on the heart: new tool spots rare amyloidosis earlier

NCT ID NCT07529860

Diagnosis Sponsor: Germans Trias i Pujol Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an artificial intelligence (AI) program can help doctors identify a rare heart condition called cardiac amyloidosis on routine echocardiograms. The condition causes protein buildup in the heart muscle, leading to heart failure, and is often missed early on. Researchers will enroll 200 adults with thickened heart walls and use the AI tool to flag suspicious cases, which will then be confirmed with specialized scans and blood tests.

What this could mean

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

Active substance
AI-based echocardiogram (Us2.ai software)
What this could lead to
If successful, this AI tool could help doctors diagnose cardiac amyloidosis earlier and more accurately, leading to timely treatment and better outcomes.
What could go wrong
This is a relatively small, early-stage study (200 participants) focused on detection accuracy, not treatment. The AI may not perform as well in broader, real-world settings.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 95 years

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: * Patients 18 years old or older * Left ventricular hypertrophy defined by a wall thickness of at least 12 mm * Echocardiographic red flags of suspected cardiac amyloidosis * Informed consent signed Exclusion Criteria: * Patients with poor echocardiographic acoustic window to allow proper analysis of the data * Patients with known cardiac amyloidosis.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis diastolic heart failure Hypertrophy, Left Ventricular Sprains and Strains

As listed by the trial registrant

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

Cardiac amyloidosis Heart failure with preserved ejection fraction (hfpef Left ventricular hypertrophy

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.