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Eye scans could spot deadly heart disease before symptoms appear

NCT ID NCT07690436

Diagnosis Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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Status unknown
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First seen Jul 08, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study explores whether specialized eye imaging can identify people with a rare heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). Researchers will use machine learning to analyze eye scans from 500 adults—some with ATTR-CM and others with heart failure but not ATTR-CM. The goal is to see if the eyes can serve as a window to the heart, offering a non-invasive screening method.

What this could mean

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

What this could lead to
If successful, this could lead to a simple, non-invasive eye test to screen for a serious heart condition, potentially catching it earlier.
What could go wrong
This is an early pilot study. The machine learning model may not be accurate enough, and eye imaging might not reliably distinguish ATTR-CM from other heart conditions.

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 500 people

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

Started

Jul 2026

Expected to finish

Jun 2027

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

The study population will comprise adult participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure (HF) controls who have documentation within the past 2 years that either excludes ATTR-CM or indicates a low probability of ATTR-CM.

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: * 1\. Participant must be 18 years and older at the time of signing the informed consent form. * 2\. Participants with either of the following: * \- Positive ATTR-CM cases: Participants with a clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) with amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining, or DPD-Tc, PYP-Tc, or HMDP-Tc scintigraphy with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio. * \- Control population: Participants with a clinical diagnosis of guideline-directed medical therapy-directed heart failure (HF) and either: * a) Subgroup A: Definitively excluded ATTR-CM amyloidosis: negative cardiac or non-cardiac tissue biopsy for amyloid, or negative technetium scintigraphy within the past 2 years. * b) Subgroup B: Low probability of ATTR-CM amyloidosis, not definitively excluded: absence of amyloid-suggestive features on echocardiography (ECHO), electrocardiography (ECG), or cardiac magnetic resonance imaging (MRI) within the past 2 years, with documented clinical assessment indicating HF etiology unlikely attributable to amyloidosis; no amyloid-specific testing (technetium scintigraphy or biopsy) performed. * 3\. Participant or legally authorized representative (LAR) must sign the informed consent form. Exclusion Criteria: * 1\. Any known eye condition that may preclude clear imaging of the retina. * 2\. Any known history of amyloid light-chain (AL) amyloidosis. * 3\. Any ocular surgery that, in the opinion of the investigator, makes participation in the study undesirable. * 4\. Any medical condition that, in the opinion of the investigator, makes participation in the study undesirable, for example, if the participant is critically unwell or requires ongoing emergency treatment. * 5\. Involvement in the planning and/or conduct of the study. * 6\. In the opinion of the investigator, the participant is unlikely to comply with study procedures, restrictions, and requirements. * 7\. Previous enrollment in the present study.

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Conditions

The condition(s) this trial relates to.

heart failure wild type ATTR amyloidosis

As listed by the trial registrant

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

Transthyretin amyloid cardiomyopathy

How to take part

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

  1. The places running it

    20 sites in 5 countries. 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

  • Research Site

    NOT_YET_RECRUITING

    Palo Alto, California, 94305, United States

  • Research Site

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Research Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    NOT_YET_RECRUITING

    Portland, Oregon, 97239-3098, United States

  • Research Site

    NOT_YET_RECRUITING

    Germantown, Tennessee, 38138, United States

  • Research Site

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Research Site

    NOT_YET_RECRUITING

    Essen, 45147, Germany

  • Research Site

    NOT_YET_RECRUITING

    Frankfurt am Main, 60596, Germany

  • Research Site

    NOT_YET_RECRUITING

    Würzburg, 97078, Germany

  • Research Site

    RECRUITING

    Guimarães, 4835-044, Portugal

  • Research Site

    NOT_YET_RECRUITING

    Lisbon, 1169-024, Portugal

  • Research Site

    NOT_YET_RECRUITING

    Lisbon, 1649-028, Portugal

  • Research Site

    NOT_YET_RECRUITING

    Lisbon, 2799-523, Portugal

  • Research Site

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, 08907, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Research Site

    NOT_YET_RECRUITING

    Palma de Mallorca, 07198, Spain

  • Research Site

    NOT_YET_RECRUITING

    Gothenburg, 413 45, Sweden

  • Research Site

    NOT_YET_RECRUITING

    Solna, 171 64, Sweden

  • Research Site

    NOT_YET_RECRUITING

    Vasterbottens Lan, 907 37, Sweden

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