NCT07690436 · AstraZeneca
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
What this study is about
This conducted at multiple hospitals 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.
View original scientific 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.
Primary outcome measures
Comparison of per-participant confidence scores distributions between ATTR-CM cases and HF controls without ATTR-CM
Time frame: At 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 pathology
Time frame: At 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Palo Alto, California
- Jacksonville, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Portland, Oregon
- Germantown, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations