About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
eMyosound SAS
Lead sponsor
Massachusetts General Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
Boston Medical Center
Collaborator