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

150 Participants
are grouped into 3 trial groups

Locations

3
Boston Medical Center02118, BostonMassachusetts, United States
Brigham and Women's Hospital02116, BostonMassachusetts, United States
Massachusetts General Hospital02114, BostonMassachusetts, United States

Sponsors and collaborators

eMyosound SAS

Lead sponsor

Massachusetts General Hospital

Collaborator

Brigham and Women's Hospital

Collaborator

Boston Medical Center

Collaborator