Study of Shear Wave Velocity Measurements in Heart Failure Patients with Preserved Ejection Fraction and Control Subjects Using the eMyosound LYRA Device

What this Trial Is About

Researchers are investigating the use of shear wave velocity SWV measurements to assess heart and liver stiffness in patients with heart failure who have a non-reduced left ventricular ejection fraction LVEF and left ventricular hypertrophy LVH. The study includes patients with transthyretin amyloidosis cardiomyopathy ATTR-CM, patients without ATTR-CM, and a control group without heart failure or cardiomyopathy. This observational study aims to better understand how SWV relates to myocardial and hepatic stiffness and its correlation with clinical, ECG, laboratory, and echocardiographic findings. Participants will undergo one study visit lasting approximately 2.5 hours, during which standard cardiology assessments will be performed including a physical exam, medical history, blood tests, ECG, and echocardiogram. They will also receive investigational elastography measurements using the eMyosound LYRA device, which records myocardial and liver SWV in specific heart and liver regions. Two observers will independently perform repeated measurements to evaluate the reliability of the SWV assessments. During the visit, participants will complete all assessments in a single session without the need for further follow-up visits. Researchers will analyze SWV data to determine its distribution across the three groups and its repeatability between observers. Safety will be monitored, and statistical analyses will explore associations between SWV and other clinical parameters. The total participation time is around 2.5 hours with no additional visits required.

US Benchmarking Clinical Study