Ocular Imaging to help detect ATTR-CM in adults with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational pilot enrolls adults with confirmed ATTR-CM and heart failure controls without ATTR-CM to collect ocular images along with other data. The goal is to build and preliminarily evaluate a machine learning model that can differentiate ATTR-CM cases from non-ATTR-CM heart failure. Participants will be followed during the study period, with possible discontinuation for non-completion or withdrawal, and no penalties for withdrawal. The study will use imaging and clinical data to explore whether ocular features can contribute to future noninvasive screening approaches.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Guimarães, Portugal Recruiting
• Research Site
  Palo Alto, California, United States Not yet recruiting
• Research Site
  Jacksonville, Florida, United States Not yet recruiting
• Research Site
  Chicago, Illinois, United States Not yet recruiting
• Research Site
  Boston, Massachusetts, United States Not yet recruiting
• Research Site
  Portland, Oregon, United States Not yet recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Coramitug PET/CT imaging to track and affect heart amyloid in ATTR-CM

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• Switching from tafamidis to acoramidis to see how transthyretin blood levels change

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• Characterizing wild-type transthyretin amyloidosis cardiomyopathy and its impact on quality of life

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.