RecruitingNCT07215715

US Benchmarking Clinical Study

Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study


Sponsor

eMyosound SAS

Enrollment

150 participants

Start Date

Sep 16, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This US benchmarking study is collecting heart measurements using ultrasound in three groups of people aged 60 and over: those with heart failure with preserved pumping function (HFpEF), those with the same condition plus a protein deposit disease called ATTR cardiomyopathy, and healthy controls. The goal is to test and validate new ultrasound measurement technology. **You may be eligible if...** - You are 60 years of age or older - For heart failure groups: You meet criteria for heart failure with preserved ejection fraction, with or without a confirmed ATTR cardiomyopathy diagnosis - For the control group: You have no diagnosis of heart failure or cardiomyopathy **You may NOT be eligible if...** - You are pregnant or pre-menopausal - You have had a heart attack in the past 30 days or have an uncontrolled fast heart rate - You have a mechanical heart valve or cardiac assist device - You have severe kidney disease (on dialysis or near-dialysis) - You have moderate or severe liver disease - You have had a heart, lung, liver, or kidney transplant - You have certain heart abnormalities, such as irregular heart rhythm at the time of measurement or severe valve disease from non-ATTR causes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

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NCT07215715


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