HFpEF - Heart Failure With Preserved Ejection FractionEMS-CT-1NCT07215715
US Benchmarking Clinical Study
An observational study of HFpEF - Heart Failure With Preserved Ejection Fraction and HFmrEF, run by eMyosound SAS at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction, HFmrEF, ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Sep 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or female age ≥ 60 years
- Signed informed consent and able to comply with protocol
- Inclusion Criteria Common to the Heart Failure with non-reduced left ventricular ejection fraction (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:
- 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
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- 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
Who cannot join
- 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
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- 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
- Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hanna K Gaggin, M.D., 617-726-2709, hgaggin@mgh.harvard.edu
Hanna K Gaggin, M.D.
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02116
Sarah Cuddy, M.D., 863-303-6799, scuddy1@bwh.harvard.edu
Sarah Cuddy, M.D.
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Denise M Fine, 781-293-9146, Denise.Fine@bmc.org
Deepa M Gopal, M.D.
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- 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
- Medical subject headings
- Hypertrophy, Left Ventricular, Amyloid Neuropathies, Familial, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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].
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: single-study visit of a duration of approximatively 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start16 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eMyosound SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Thierry Sarda, Study director, eMyosound SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215715
- Sponsor's protocol ID
- EMS-CT-1
- Acronym
- EMS-CT-1
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study
- ClinicalTrials.gov ID
- NCT07215715
- Acronym / sponsor ID
- EMS-CT-1 / EMS-CT-1
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- eMyosound SASIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Boston Medical Center
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Male or female age ≥ 60 years
- Signed informed consent and able to comply with protocol
- Inclusion Criteria Common to the Heart Failure with non-reduced left ventricular ejection fraction (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:
- Patients meeting the Universal Definition of Heart Failure \& HeartShare study criteria.
- LVEF >40% on the last available imaging study
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions.
Time frame: single study visit of a duration of approximatively 2.5 hours
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.
9 secondary outcomes
The secondary outcome measures are comprehensive and are used to establish distributions, assess device performance, and explore associations with clinical data
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).
Time frame: single-study visit of a duration of approximatively 2.5 hours
Distribution of hepatic 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)
Time frame: single-study visit of a duration of approximatively 2.5 hours
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
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
Time frame: single-study visit of a duration of approximatively 2.5 hours
Safety of the procedure
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
Time frame: single-study visit of a duration of approximatively 2.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry Sarda study director
eMyosound SAS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFpEF - Heart Failure With Preserved Ejection Fraction and HFmrEF, run by eMyosound SAS at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director Clinical Operations (+33781549847, clinical@emyosound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions. (time frame: single study visit of a duration of approximatively 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.