The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy.
The main question it aims to answer is:
• Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population.
Participants will:
* Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram. * Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver. * Have the investigational assessment repeated by a second observer to assess measurement reliability.
Male or female age ≥ 60 years
Signed informed consent and able to comply with protocol
Patients meeting the Universal Definition of Heart Failure & HeartShare study criteria.
LVEF >40% on the last available imaging study
Pregnant OR pre-menopausal woman
Vulnerable patients
Acute Coronary Syndrome within 30 days
Heart rate greater than 130 beats/minute at the time of the measurements
The study population is composed of three distinct groups, or cohorts, participating in a multicenter study. The total target enrollment is 150 analyzable patients, with 50 patients per arm from each of the three sites. An additional 30 patients may be enrolled to account for non-contributing data. The study focuses on individuals aged 60 and older, with no upper age limit.
Cohort
Prospective
Not listed
The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions.
These measurements include: Myocardial Acoustic Radiation Force (ARF)-SWV, defined as the velocity projected along the muscle fibers during diastasis. Myocardial Natural (N)-SWV, measured during both mitral valve closure (MVC) and aortic valve closure (AVC). Hepatic ARF-SWV, measured in two distinct regions of the right liver lobe.
The secondary outcome measures are comprehensive and are used to establish distributions, assess device performance, and explore associations with clinical data
The proportion of patients for whom SWV can be estimated in each region of interest (ROI) and each view \[Parasternal Long Axis (PLAX) view, Parasternal Short Axis (PSAX) view, Apical Four Chamber (A4C) view\].
Distribution of myocardial Acoustic Radiation Force - Shear Wave Velocity (ARF-SWV) and myocardial Natural - Shear Wave Velocity (N-SWV).
Establish the distribution of myocardial ARF-SWV and myocardial N-SWV.
Distribution of hepatic ARF-SWV.
Establish the distribution of hepatic Acoustic Radiation Force - Shear Wave Velocity (ARF-SWV).
Within-observer repeatability of Shear Wave Velocity (SWV) measurements per Region of Interest (ROI)
Establish the within-observer repeatability of SWV measurements per ROI
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eMyosound SAS
Lead sponsor
Massachusetts General Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
Boston Medical Center
Collaborator
