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

Starting soon

Conditions studied: Transthyretin Amyloid Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT07690436

Run by

AstraZeneca

People needed

500

Starts

2026-07-02

Expected to finish

2027-06-03

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Palo Alto, California, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Portland, Oregon, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Essen, Germany
• Research Site — Würzburg, Germany
• Research Site — Guimarães, Portugal
• Research Site — L'Hospitalet de Llobregat, Spain
• Research Site — Palma de Mallorca, Spain

Full record on ClinicalTrials.gov

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