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

Conditions

• Transthyretin Amyloid Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Jul 8, 2026

Start date

Jul 2, 2026

Status verified

Jul 2026

Primary completion

Jun 3, 2027

Completion

Jun 3, 2027

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: ATTR-CM
  Participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM).
• Arm: HF Control
  Participants with guideline-directed medical therapy-directed heart failure and documentation within the past 2 years that either excludes transthyretin amyloid cardiomyopathy (ATTR-CM) or indicates a low probability of ATTR-CM.

Primary Outcome Measure

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 ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (5)

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