Actively Recruiting

Age: 60Years +
All Genders
Healthy Volunteers
NCT07215715

US Benchmarking Clinical Study

Led by eMyosound SAS · Updated on 2025-10-20

150

Participants Needed

3

Research Sites

41 weeks

Total Duration

On this page

Sponsors

E

eMyosound SAS

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

US Benchmarking Clinical Study

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female age 60 years or older
  • Signed informed consent and able to comply with protocol
  • Patients meeting the Universal Definition of Heart Failure and HeartShare study criteria (for heart failure arms)
  • Left ventricular ejection fraction greater than 40% on latest imaging (for heart failure arms)
  • Left ventricular hypertrophy defined as left ventricular mass index greater than 95 g/m82 in females or greater than 115 g/m82 in males, or interventricular septum thickness 6 12 mm
  • Negative Pyrophosphate scintigraphy within 24 months, Simple Score <643, or negative endomyocardial biopsy (for heart failure without ATTR-CM arm)
  • Confirmed ATTR-CM with monoclonal protein AL amyloidosis ruled out (for heart failure with ATTR-CM arm)
  • No diagnosis of heart failure or cardiomyopathy (for control subjects)
  • No diagnosis of transthyretin amyloid cardiomyopathy or amyloid light-chain amyloidosis (for control subjects)
Not Eligible

You will not qualify if you...

  • Pregnant or pre-menopausal women
  • Vulnerable patients
  • Acute coronary syndrome within 30 days
  • Heart rate greater than 130 beats per minute at time of measurements
  • Atrial fibrillation or flutter at time of SWV measurement (history allowed if in sinus rhythm during measurement)
  • Clinically significant cardiac arrhythmia at time of SWV measurement
  • Poor echogenicity preventing accurate ultrasound measurements
  • Segmental wall motion abnormalities due to myocardial infarction
  • Severe mitral or aortic valve disease not caused by ATTR
  • Severe tricuspid valve disease not caused by ATTR
  • Skin to interventricular septum distance greater than or equal to 8 cm
  • Any prosthetic mechanical valve
  • Mechanical cardiac assist devices except pacemakers or defibrillators
  • History or expected heart, lung, liver, or kidney transplant within next year
  • Severe renal impairment with eGFR below 15 mL/min/1.73m82 or dialysis
  • Life-threatening risks expected within 12 months
  • Uncontrolled diabetes with HbA1c 9% or higher and organ damage
  • Uncontrolled high blood pressure with diastolic over 100 mmHg or systolic over 160 mmHg
  • Acute decompensated state such as volume overload
  • Skin abnormalities, infections, or open wounds at measurement site
  • At least moderate liver disease
  • Known inherited or infiltrative cardiomyopathies other than ATTR-CM
  • History of treatment with transthyretin depleters for ATTR-CM
  • Diagnosis of cardiomyopathy or heart failure (for control subjects)
  • Left ventricular hypertrophy or interventricular septum thickness meeting study thresholds unless due to athlete's heart (for control subjects)

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02116

Actively Recruiting

3

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

D

Director Clinical Operations

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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