Eye Imaging to Help Detect Transthyretin Amyloid Heart Disease
Studies eye scans as a possible way to spot ATTR-CM in adults.
Plain-language title generated from the registry record
Registry title: Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
Key facts
- Where
- Boston, Chicago, Germantown, Jacksonville, Palo Alto, and Portland, United StatesSee the 6 sites
Where in United States
- BostonBoston, United StatesNot yet recruiting
- ChicagoChicago, United StatesNot yet recruiting
- GermantownGermantown, United StatesNot yet recruiting
- JacksonvilleJacksonville, United StatesNot yet recruiting
- Palo AltoPalo Alto, United StatesNot yet recruiting
- PortlandPortland, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07690436
- Record updated
- 26 August 2026
- Original description
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.Read full original descriptionShow less
A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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.
Inclusion: 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: 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.