US Benchmarking Clinical Study

NCT07215715 | Recruiting DMC

• 1 other identifier: EMS-CT-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction; HFmrEF; ATTR-CM (Transthyretin Amyloid Cardiomyopathy); Left Ventricular Hypertrophy; Cardiac Amyloidosis

Keywords

Shear Wave Velocity; non-invasive ultrasound elastography; US Benchmarking Clinical Study; Heart Failure; Cardiac Amyloidosis; ATTR-CM

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions.

  These measurements include: Myocardial Acoustic Radiation Force (ARF)-SWV, defined as the velocity projected along the muscle fibers during diastasis. Myocardial Natural (N)-SWV, measured during both mitral valve closure (MVC) and aortic valve closure (AVC). Hepatic ARF-SWV, measured in two distinct regions of the right liver lobe.

  single study visit of a duration of approximatively 2.5 hours

Secondary Outcomes (9)

• The secondary outcome measures are comprehensive and are used to establish distributions, assess device performance, and explore associations with clinical data

  single-study visit of a duration of approximatively 2.5 hours

• Distribution of myocardial Acoustic Radiation Force - Shear Wave Velocity (ARF-SWV) and myocardial Natural - Shear Wave Velocity (N-SWV).

  single-study visit of a duration of approximatively 2.5 hours

• Distribution of hepatic ARF-SWV.

  single-study visit of a duration of approximatively 2.5 hours

• Within-observer repeatability of Shear Wave Velocity (SWV) measurements per Region of Interest (ROI)

  single-study visit of a duration of approximatively 2.5 hours

• Between-observer reliability of SWV measurements per ROI

  single-study visit of a duration of approximatively 2.5 hours

Study Arms (3)

Heart Failure with LVEF > 40% and LVH with ATTR-CM

heart failure (HF) with left ventricular ejection fraction (LVEF) \> 40% and left ventricular hypertrophy (LVH) with transthyretin amyloidosis with cardiomyopathy (ATTR-CM)

Heart Failure with LVEF > 40% and LVH, without ATTR-CM

Heart Failure with LVEF \> 40% and LVH, without ATTR-CM

Control group of patients without heart failure or cardiomyopathy

Control group of patients without heart failure or cardiomyopathy.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is composed of three distinct groups, or cohorts, participating in a multicenter study. The total target enrollment is 150 analyzable patients, with 50 patients per arm from each of the three sites. An additional 30 patients may be enrolled to account for non-contributing data. The study focuses on individuals aged 60 and older, with no upper age limit.

You may qualify if:

• 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
• Left ventricular hypertrophy (LVH) defined as left ventricular mass index (mass/BSA) in female \> 95 g/m², in male \> 115 g/m² according to American Society of Echocardiography/European Association of Cariology (ASE/EAC) guidelines42 OR as interventricular septum (IVS) thickness ≥12 mm
• Negative (grade 0) Pyrophosphate (PYP) scintigraphy within 24 months prior to the enrolment in the study OR Simple Score \<643 OR negative endomyocardial biopsy
• ATTR-CM objectively confirmed and classified at any time prior to the enrollment in the study, with monoclonal protein AL amyloidosis ruled out, according to American Heart Association (AHA) 2020 criteria
• No diagnosis of HF or cardiomyopathy according to the universal definition of Heart Failure
• No diagnosis of Transthyretin amyloid cardiomyopathy (ATTR-CM) or Amyloid light-chain (AL) amyloidosis

You may not qualify if:

• 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
• Atrial fibrillation or flutter at the time of SWV measurement (history of AF is authorized provided they patient is in sinus rhythm at the time of the measurements)
• Any clinically significant cardiac arrhythmia at the time of SWV measurement
• Poor echogenicity preventing accurate ultrasound measurements
• Patients with segmental wall motion abnormalities thought to be due to myocardial infarction.
• Severe mitral or aortic valve disease (regurgitation or stenosis) excluded if the cause is other than ATTR (e.g., prolapse, endocarditis, prosthetic valve.)
• Severe tricuspid valve disease (regurgitation or stenosis) excluded if the causes are other than ATTR.
• Distance from skin to IVS ≥ 8 cm
• Any prosthetic mechanical valve
• Patients with mechanical cardiac assist devices other than pacemakers or defibrillators
• Heart, lung, liver or kidney transplant history or expected in the next year
• Severe renal impairment with eGFR \< 15 mL/min/1.73m² or end-stage renal disease or patient on dialysis.

Sponsors & Collaborators

• eMyosound SAS: lead
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• Boston Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02116, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Amyloid Neuropathies, Familial; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Thierry Sarda

  eMyosound SAS

  STUDY DIRECTOR

Central Study Contacts

Director Clinical Operations

CONTACT

+33781549847; clinical@emyosound.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 10, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)