NCT07690436Recruiting
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 8 Jul 2026
- Primary completion date
- 18 Jun 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT07690436
What you commit to
- Study type: Observational
- Planned participants: 500
- From 8 Jul 2026 to the primary completion date, 18 Jun 2027
- 18 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Any ocular surgery that, in the opinion of the investigator, makes participation in the study undesirable.
- 7\. Previous enrollment in the present study.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.