US Benchmarking Clinical Study
Eligible age
60+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this 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.
Sponsor: eMyosound SAS
You may qualify if…
- ✓ 1. Male or female age ≥ 60 years
- ✓ 2. Signed informed consent and able to comply with protocol
- ✓ 3. Patients meeting the Universal Definition of Heart Failure \& HeartShare study criteria.
- ✓ 4. LVEF \>40% on the last available imaging study
- ✓ 5. 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:
- ✓ 6. 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:
You may not qualify if…
- ✕ 1. Pregnant OR pre-menopausal woman
- ✕ 2. Vulnerable patients
- ✕ 3. Acute Coronary Syndrome within 30 days
- ✕ 4. Heart rate greater than 130 beats/minute at the time of the measurements
- ✕ 5. 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)
- ✕ 6. Any clinically significant cardiac arrhythmia at the time of SWV measurement
- ✕ 7. Poor echogenicity preventing accurate ultrasound measurements
- ✕ 8. Patients with segmental wall motion abnormalities thought to be due to myocardial infarction.
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT07215715 · last updated 2025-10-20