Study of Wild-Type Transthyretin Amyloidosis Cardiomyopathy Patients in Denmark Investigating Disease Severity, Quality of Life, and Protein Markers

What this Trial Is About

This observational study focuses on patients with wild-type transthyretin amyloidosis cardiomyopathy ATTRwt-CM, aiming to understand how the severity of this heart condition relates to patients quality of life. Researchers also seek to measure specific protein fragments, misfolded transthyretin misTTR and fragmented transthyretin fragTTR, in body fluids and tissue samples, and to explore their connection with disease severity. The study includes a control group of heart-healthy individuals for comparison. Participants include 100 ATTRwt-CM patients across all stages of disease severity and 20 healthy controls. Patients undergo comprehensive assessments including clinical history, physical exams, ECG, advanced echocardiography, blood and urine tests, cardiac magnetic resonance imaging, and quality of life questionnaires. A smaller subgroup of 10 patients will have an endomyocardial biopsy to further analyze protein fragments. Throughout the study, participants will complete quality of life surveys KCCQ, EQ-5D-5L, and ATTR-QoL and undergo detailed heart imaging and laboratory tests. Researchers will monitor the relationship between amyloidosis severity, quality of life, and protein fragment levels over two years. The study aims to develop tools to better evaluate and track disease progression and patient well-being.

Phenotyping and Characterization of wtATTR-CM (TRACE 1)