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

NCT07690436 · AstraZeneca
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Official title
A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
About this study
A participant who does not complete the study within 90 days from enrollment will be discontinued from the study. A participant may be discontinued from the study at any time at the discretion of the investigator for behavioral or compliance reasons. A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights.
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.
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-07-08
Estimated completion: 2027-06-18
Last updated: 2026-08-26
Primary outcomes
  • Comparison of per-participant confidence scores distributions between ATTR-CM cases and HF controls without ATTR-CM (At a single assessment time point within 90 days following informed consent form signing)
  • Qualitative assessment of features learned indicative of ATTR pathology (At a single assessment time point within 90 days following informed consent form signing)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (20)
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Palo Alto, California, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Portland, Oregon, United States
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Germantown, Tennessee, United States
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Berlin, Germany
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Essen, Germany
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Frankfurt am Main, Germany
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Würzburg, Germany
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Guimarães, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Gothenburg, Sweden
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Solna, Sweden
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Vasterbottens Lan, Sweden