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Observational Study on Retinal Imaging for ATTR-CM

This study is looking at whether special eye scans, called retinal fundus imaging and OCT imaging, can help detect transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a condition where abnormal proteins build up in the heart, causing heart failure. We are studying adults who have already been diagnosed with ATTR-CM and comparing their eye scans to those of people with heart failure but without ATTR-CM. The goal is to see if these eye scans can help us develop a computer program to tell the difference between these two groups. We want to see if certain features in the eye scans are linked to ATTR-CM. This study aims to enroll 500 participants.

Study design
This is an observational study involving 500 participants. It is not specified if it is randomized or blinded.
What's involved
You would have your eye imaging and other study data collected at a single visit within 90 days of joining. The study will end for you if you don't complete it within 90 days.
Compensation
Not stated in the trial record.
Follow-up
Your participation involves a single assessment time point within 90 days after you sign the consent form.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07690436

Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM

Recruiting
Not specifiedAges 18+Observational
AstraZeneca
~500 participants
Updated 2026-08-26 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of per-participant confidence scores distributions between ATTR-CM cases and HF controls without ATTR-CM
Measured over At a single assessment time point within 90 days following informed consent form signing
+1 more outcome measured

Conditions

Transthyretin Amyloid Cardiomyopathy

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NCT07690436

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Palo Alto, Californiano site contact published

    Not yet recruiting

  • Research Site

    Jacksonville, Floridano site contact published

    Not yet recruiting

  • Research Site

    Chicago, Illinoisno site contact published

    Not yet recruiting

  • Research Site

    Boston, Massachusettsno site contact published

    Not yet recruiting

  • Research Site

    Portland, Oregonno site contact published

    Not yet recruiting

  • Research Site

    Germantown, Tennesseeno site contact published

    Not yet recruiting

  • Research Site

    Berlin, Germanyno site contact published

    Not yet recruiting

  • Research Site

    Essen, Germanyno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Comparison of per-participant confidence scores distributions between ATTR-CM cases and HF controls without ATTR-CMAt a single assessment time point within 90 days following informed consent form signing

    Per-participant confidence score distributions generated by the machine learning (ML) model will be compared between participants with clinically confirmed transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure controls without ATTR-CM.

  • Qualitative assessment of features learned indicative of ATTR pathologyAt a single assessment time point within 90 days following informed consent form signing

    Features learned by the machine learning (ML) model that are indicative of transthyretin amyloid pathology will be qualitatively assessed.