Study of New Imaging Techniques to Understand and Track Cardiac Transthyretin Amyloidosis Progression Using PETCT, MRI, and Ultrasound Scans with Tafamidis Treatment

What this Trial Is About

Researchers are investigating whether new imaging techniques can improve understanding of cardiac amyloidosis, a condition where the disease progresses despite treatment in about one-third of patients. The study aims to learn more about the biological changes in the heart muscle and why treatment is not effective for all patients. This open-label, prospective study involves 50 participants diagnosed with cardiac transthyretin amyloidosis ATTR-CM following recent multi-societal criteria. Participants will undergo additional imaging tests, including heart ultrasound, cardiac MRI, and cardiac PET scans using a FAPI tracer, at the start of the study and after one year. Blood samples will be collected for BMP4 serum concentration analysis. These tests are designed to monitor changes over time, with a focus on myocardial stiffness and other markers. The study includes clinical, functional, laboratory, and imaging evaluations to track disease progression. During the study, participants will have heart ultrasound, cardiac MRI, and PET scans taking from 5 to 10 minutes for ultrasound and about 2 hours each for MRI and PET. Questionnaires will also be completed at baseline. Researchers will measure changes in FAPI uptake, myocardial stiffness, extracellular volume, and BMP4 expression over 12 months. Safety and clinical status will be monitored through hospital records, walk tests, and heart function questionnaires. The study duration is one year with two main assessment visits.

Multimodality Cardiac Imaging for Disease Progression in ATTR-CM