The goal of this study is to learn whether PET-CT imaging using evuzamitide can help diagnose transthyretin cardiac amyloidosis (ATTR-CA) in patients whose standard nuclear imaging results are unclear but who have elevated TAD1 levels in their blood. The main question it aims to answer is:
Can evuzamitide PET-CT imaging detect signs of cardiac amyloidosis in patients with non-diagnostic nuclear scintigraphy but elevated TAD1 levels? Participants who meet eligibility criteria will receive a single PET-CT scan with evuzamitide and will be followed for approximately 28 days to monitor safety and collect additional clinical information.
Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure.
Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1).
Elevated levels of Transthyretin Amyloid Detector-1 (TAD1).
No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.
Primary amyloidosis (AL) or secondary amyloidosis (AA).
Ventricular assist device.
Disabling dementia or other mental or behavioral disease.
Enrollment in a clinical trial not approved for co-enrollment.
Lorena Saelices
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator