US Benchmarking Clinical Study

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 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.

Eligibility

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

Conditions6

Locations3 sites

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