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

RecruitingObservational study

A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

Sponsor: AstraZeneca · Participants: 500 · Started: Jul 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07690436

Locations in the U.S.

CaliforniaResearch Site, Palo Alto (Not yet recruiting)
FloridaResearch Site, Jacksonville (Not yet recruiting)
IllinoisResearch Site, Chicago (Not yet recruiting)
MassachusettsResearch Site, Boston (Not yet recruiting)
OregonResearch Site, Portland (Not yet recruiting)
TennesseeResearch Site, Germantown (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.