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
eMyosound SAS
150 participants
Sep 16, 2025
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
Inclusion Criteria11
- 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
- Inclusion criterion specific to HF with non-reduced LVEF without ATTR-CM Arm:
- Negative (grade 0) Pyrophosphate (PYP) scintigraphy within 24 months prior to the enrolment in the study OR Simple Score \<643 OR negative endomyocardial biopsy
- Inclusion criterion specific to HF with non-reduced LVEF with ATTR-CM Arm:
- 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
Exclusion Criteria25
- 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.
- Presence of any competing life-threatening risk over the next 12 months
- Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage.
- Uncontrolled and persistent high-blood pressure with diastolic pressure \> 100 mmHg or systolic pressure \> 160 mmHg at the time of the measurement.
- Acute decompensated state such as volume overload, etc. in the opinion of the study investigator
- Skin abnormalities, infections, or open wounds at the site of the SVW measurement
- Liver disease, at least moderate
- Known inherited cardiomyopathy, infiltrative cardiomyopathy (other than ATTR-CM for the study arm for ATTR-CM), cardiomyopathy from muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), hypertrophic cardiomyopathy or known pericardial constriction
- History of treatment for ATTR-CM with Transthyretin (TTR) depleters
- Any diagnosis of cardiomyopathy or HF, whatever the cause46
- LVH based on LV mass index female \>95 g/m², in male ≥115 g/m² OR IVS thickness ≥12 mm unless thought to be due to athlete's heart
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07215715