An observational study in HFpEF - Heart Failure With Preserved Ejection Fraction, HFmrEF and ATTR-CM (Transthyretin Amyloid Cardiomyopathy), sponsored by eMyosound SAS. Recruiting at 3 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by eMyosound SAS · Observational
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:
Participants will:
This is a multicenter, prospective, consecutive cross-sectional study with three parallel arms and non-competitive enrollment. The study is designed to advance the clinical understanding of myocardial and hepatic stiffness by using a novel ultrasound elastography device, the eMyosound LYRA. The prospective design is essential because this elastographic assessment is not yet part of standard care, and the investigational device is being made available specifically for this research. Consecutive recruitment will be used to minimize selection bias by inviting all eligible patients to participate. The cross-sectional design means that no longitudinal follow-up visits are required, making the study feasible for a single-visit assessment.
The primary objective is to determine the shear wave velocity (SWV) in the left ventricle, right ventricle, and liver of three distinct patient populations as specified in the Groups and Interventions section of this form.
The study also aims to establish the device's proportion of patients in whom SWV can be estimated, to characterize the distribution of various myocardial and hepatic SWV measurements, and to compare these distributions between the three study arms. We will also investigate the statistical associations between SWV and a range of clinical, ECG, laboratory, and echocardiographic variables to better understand how these parameters correlate with myocardial stiffness. A key part of our methodology involves a test-retest procedure with two independent observers to establish the within-observer repeatability and between-observer reliability of the SWV measurements.
Study Conduct and Procedures The study will enroll a total of 150 analyzable participants (50 per arm) from three medical centers. The total enrollment may reach up to 180 to account for potential dropouts or non-contributing data. The study is confined to a single visit for each participant, with a total estimated duration of 2.5 hours.
At the single visit, after informed consent is signed, patients will undergo a series of assessments. A standard medical history and physical examination will be performed. Patients will also receive a 12-lead ECG, blood work (including NT-proBNP and hsTnT), and a standard echocardiogram with a wide range of measurements.
Following these standard cardiology assessments, the investigational elastographic assessment will be performed with the eMyosound LYRA device, a Class II medical device for real-time sonographic imaging, shear wave measurement, and electrocardiographic recording. The assessment includes two types of shear wave measurements using the device's M3-5 LYRA probe:
Myocardial Shear Wave Velocity (SWV): Measurements will be taken in specific myocardial regions of interest (ROIs), including the right ventricular anterior free wall (RVAW), left ventricular anteroseptal wall (LVAW), and interventricular septum (IVS). These measurements are acquired in both parasternal long-axis (PLAX) and parasternal short-axis (PSAX) views, and the IVS is also measured in the apical 4-chamber (A4C) view.
Hepatic Shear Wave Velocity (SWV): The operator will measure SWV in two distinct ROIs of the liver's right lobe.
The types of measurements include Acoustic Radiation Force Induced Shear Waves (ARF-SWV), which are performed during diastasis, and Natural Shear Waves (N-SWV), which are produced by cardiac movements. For the test-retest procedure, each of the two observers will attempt to acquire 20 repeated valid measurements for each target ROI.
Risk and Safety Management The study is designed to minimize risks, which are similar to those of other echocardiographic devices. Risk management is handled by respecting the device's indications and contraindications and providing detailed training and technical support to investigators. The potential benefit to participants is a free, thorough cardiological assessment. A Data and Safety Monitoring Board (DSMB) will provide independent oversight, review all adverse events, and make recommendations to the sponsor.
Statistical Analysis The study is primarily descriptive and exploratory. The target sample size is 150 analyzable patients. The final analysis will be performed once all participants have completed the study. Two interim analyses are planned: a qualitative analysis after the first 15 patients to check for safety issues and a quantitative analysis after the first 75 patients to check data quality.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's planned enrollment of 150 is below the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →This is the only study on the registry with eMyosound SAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Inclusion Criteria Common to all three Study Arms:
Signed and able to comply with protocol
Inclusion Criteria Common to the Heart Failure with non-reduced (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:
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
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
Inclusion criteria in Control Subjects:
Exclusion Criteria:
Exclusion criteria common to the three arms:
Liver disease, at least moderate
Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:
History of treatment for ATTR-CM with Transthyretin (TTR) depleters
Exclusion criteria Specific to Control Subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Control group of patients without heart failure or cardiomyopathy.
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.
Time frame: single study visit of a duration of approximatively 2.5 hours
The secondary outcome measures are comprehensive and are used to establish distributions, assess device performance, and explore associations with clinical data
The proportion of patients for whom SWV can be estimated in each region of interest (ROI) and each view \[Parasternal Long Axis (PLAX) view, Parasternal Short Axis (PSAX) view, Apical Four Chamber (A4C) view\].
Time frame: 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).
Establish the distribution of myocardial ARF-SWV and myocardial N-SWV.
Time frame: single-study visit of a duration of approximatively 2.5 hours
Distribution of hepatic ARF-SWV.
Establish the distribution of hepatic Acoustic Radiation Force - Shear Wave Velocity (ARF-SWV).
Time frame: 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)
Establish the within-observer repeatability of SWV measurements per ROI
Time frame: single-study visit of a duration of approximatively 2.5 hours
Between-observer reliability of SWV measurements per ROI
Establish the between-observer reliability of SWV measurements per ROI
Time frame: single-study visit of a duration of approximatively 2.5 hours
Comparison of SWV distributions between the three study arms
Compare the SWV distributions between the three study arms
Time frame: single-study visit of a duration of approximatively 2.5 hours
Statistical associations between the various myocardial and hepatic SWVs and study assessment variables
Identify the statistical associations between the various myocardial SWVs and the clinical, electrocardiogram (ECG), laboratory, and echocardiographic variables
Time frame: single-study visit of a duration of approximatively 2.5 hours
Safety of the procedure
Establish the safety of the procedure, documented by the number and severity of adverse events during the study visits until discharge
Time frame: single-study visit of a duration of approximatively 2.5 hours
Identify the statistical associations between the various hepatic SWVs and study assessment variables
Identify the statistical associations between the various hepatic SWVs and the clinical, electrocardiogram (ECG), laboratory, and echocardiographic variables
Time frame: single-study visit of a duration of approximatively 2.5 hours
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for Jul 2026, 10 months after the start.
Of 18 observational studies under Hypertrophy, Left Ventricular, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 58. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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