US Benchmarking Clinical Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsoreMyosound SAS

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

Sponsors and collaborators

eMyosound SAS

Lead sponsor

Massachusetts General Hospital

Collaborator

Brigham and Women's Hospital

Collaborator

Boston Medical Center

Collaborator