US benchmarking of heart and liver stiffness using shear wave ultrasound
Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study
This project will test whether a new ultrasound device can measure heart and liver stiffness using shear wave velocity in people aged 60 or older with preserved or mildly reduced ejection fraction and left ventricular hypertrophy, with or without transthyretin amyloid cardiomyopathy, and in control subjects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | eMyosound SAS Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT07215715 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cross-sectional study will use the investigational eMyosound LYRA ultrasound elastography device to measure shear wave velocity (SWV) in the left and right ventricles and the liver. Participants will receive a standard cardiology assessment (physical exam, blood work, and echocardiogram) and an SWV measurement, with a second observer repeating the measurement to test reliability. The study enrolls three parallel arms (ATTR-CM, HF without ATTR-CM, and control subjects) with consecutive recruitment to reduce selection bias. No longitudinal follow-up is required; all testing is completed in a single visit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with left ventricular hypertrophy and LVEF >40% who have HFpEF or HFmrEF (with or without ATTR-CM), as well as control subjects without heart failure or cardiomyopathy.
Not a fit: Younger patients under age 60, people with reduced LVEF (<40%), or those unable to undergo ultrasound imaging are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a simple, non-invasive ultrasound method to quantify myocardial and liver stiffness that may help in diagnosing or characterizing HFpEF/HFmrEF and ATTR-CM.
How similar studies have performed: Shear wave elastography has been used in preliminary studies to measure myocardial stiffness and liver fibrosis, but use of the eMyosound LYRA for myocardial SWV in ATTR-CM and HFpEF populations remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
Inclusion Criteria Common to all three Study Arms:
1. Male or female age ≥ 60 years
2. 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:
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:
7. 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:
8. No diagnosis of HF or cardiomyopathy according to the universal definition of Heart Failure
9. No diagnosis of Transthyretin amyloid cardiomyopathy (ATTR-CM) or Amyloid light-chain (AL) amyloidosis
Exclusion Criteria:
Exclusion criteria common to the three arms:
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.
9. Severe mitral or aortic valve disease (regurgitation or stenosis) excluded if the cause is other than ATTR (e.g., prolapse, endocarditis, prosthetic valve.)
10. Severe tricuspid valve disease (regurgitation or stenosis) excluded if the causes are other than ATTR.
11. Distance from skin to IVS ≥ 8 cm
12. Any prosthetic mechanical valve
13. Patients with mechanical cardiac assist devices other than pacemakers or defibrillators
14. Heart, lung, liver or kidney transplant history or expected in the next year
15. Severe renal impairment with eGFR \< 15 mL/min/1.73m² or end-stage renal disease or patient on dialysis.
16. Presence of any competing life-threatening risk over the next 12 months
17. Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage.
18. Uncontrolled and persistent high-blood pressure with diastolic pressure \> 100 mmHg or systolic pressure \> 160 mmHg at the time of the measurement.
19. Acute decompensated state such as volume overload, etc. in the opinion of the study investigator
20. Skin abnormalities, infections, or open wounds at the site of the SVW measurement
21. Liver disease, at least moderate
Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:
22. 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
23. History of treatment for ATTR-CM with Transthyretin (TTR) depleters
Exclusion criteria Specific to Control Subjects:
24. Any diagnosis of cardiomyopathy or HF, whatever the cause46
25. 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
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Director Clinical Operations
- Email: clinical@emyosound.com
- Phone: +33781549847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.