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Eye Imaging to Help Detect Transthyretin Amyloid Heart Disease

Studies eye scans as a possible way to spot ATTR-CM in adults.

Key facts

Who runs it
AstraZeneca
Where
Berlin, Essen, Frankfurt am Main, and Würzburg, GermanySee the 4 sitesAlso in 4 other countries, 14 sites
Trial code
Registry title
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
Status
Recruiting
People taking part
500 people, planned
Started
8 Jul 2026
Expected to end
18 Jun 2027
Type of study
Observational, 2 groups
Record updated
26 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with transthyretin amyloid cardiomyopathy (ATTR-CM), and adults with heart failure who probably do not have ATTR-CM. Eye imaging is used to study ATTR-CM.

Age
18 years and older
Sex
All sexes can join
Disease stage
Two groups: ATTR-CM confirmed by tissue staining or by a heart scan with Grade 2 or 3 uptake; or heart failure with ATTR-CM excluded or unlikely within the past 2 years.
Earlier treatment
Heart failure group: on guideline-directed medical therapy for heart failure.
Biomarker or test result
ATTR-CM group: amyloid deposits confirmed by Congo Red (or equivalent) staining, or DPD-Tc, PYP-Tc or HMDP-Tc scan with Grade 2 or 3 heart uptake, with no abnormal light chains ratio. Control group: negative biopsy or scan, or no amyloid-suggestive signs on ECHO, ECG or cardiac MRI.

Main reasons for not taking part

  • Eye condition that prevents clear imaging of the retina
  • Known history of amyloid light-chain (AL) amyloidosis
  • Eye surgery that the investigator thinks makes joining undesirable
  • Medical condition that the investigator thinks makes joining undesirable, such as being critically unwell
  • Unlikely to follow the study procedures

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 3. Any ocular surgery that, in the opinion of the investigator, makes participation in the study undesirable
  • 7. Previous enrollment in the present study
  • 1. Any known eye condition that may preclude clear imaging of the retina
  • 2. Any known history of amyloid light-chain (AL) amyloidosis
  • 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

Where in Germany

Also in 4 other countries, 14 sites

  • BerlinHospital not named in the registryNot yet recruiting
  • EssenHospital not named in the registryNot yet recruiting
  • Frankfurt am MainHospital not named in the registryNot yet recruiting
  • WürzburgHospital not named in the registryNot yet recruiting

About the trial

What the trial wants to find out

This multicenter pilot study will enroll adult participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure (HF) controls with documentation within the past 2 years that either excludes ATTR-CM or indicates a low probability of ATTR-CM. Ocular imaging and other study data will be collected to assess the feasibility of developing and preliminarily evaluating a machine learning model to discriminate ATTR-CM cases from HF controls without ATTR-CM.

The 2 groups in the trial

  • ATTR-CM

    Participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM).

  • HF Control

    Participants with guideline-directed medical therapy-directed heart failure and documentation within the past 2 years that either excludes transthyretin amyloid cardiomyopathy (ATTR-CM) or indicates a low probability of ATTR-CM.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Plain-language title
Eye Imaging to Help Detect Transthyretin Amyloid Heart DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
26 August 2026