Measuring Heart and Liver Stiffness in Heart Failure Patients

Trial details

Who runs it

eMyosound SAS

Trial code

NCT07215715

Record updated

20 October 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; 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; Patients with mechanical cardiac assist devices other than pacemakers or defibrillators; Heart, lung, liver or kidney transplant history or expected in the next year; Skin abnormalities, infections, or open wounds at the site of the SVW measurement; Liver disease, at least moderate; History of treatment for ATTR-CM with Transthyretin (TTR) depleters; 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; Severe renal impairment with eGFR < 15 mL/min/1.73m² or end-stage renal disease or patient on dialysis; Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage; Pregnant OR pre-menopausal woman; Vulnerable patients; Poor echogenicity preventing accurate ultrasound measurements; Distance from skin to IVS ≥ 8 cm; Any prosthetic mechanical valve; Presence of any competing life-threatening risk over the next 12 months; 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; 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; Any diagnosis of cardiomyopathy or HF, whatever the cause46.

ClinicalTrials.gov NCT07215715