Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria Common to all three Study Arms:
- •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
- •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
- •Inclusion criteria in Control Subjects:
- •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
排除标准
- •Exclusion criteria common to the three arms:
- •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
- •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
- •Exclusion criteria Specific to Control Subjects:
- •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
结局指标
主要结局
The primary outcome measures are the shear wave velocity (SWV) measurements extracted from the eMyosound LYRA device acquisitions.
时间窗: 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.
次要结局
- The secondary outcome measures are comprehensive and are used to establish distributions, assess device performance, and explore associations with clinical data(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).(single-study visit of a duration of approximatively 2.5 hours)
- Identify the statistical associations between the various hepatic SWVs and study assessment variables(single-study visit of a duration of approximatively 2.5 hours)
- Distribution of hepatic ARF-SWV.(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)(single-study visit of a duration of approximatively 2.5 hours)
- Between-observer reliability of SWV measurements per ROI(single-study visit of a duration of approximatively 2.5 hours)
- Comparison of SWV distributions between the three study arms(single-study visit of a duration of approximatively 2.5 hours)
- Statistical associations between the various myocardial and hepatic SWVs and study assessment variables(single-study visit of a duration of approximatively 2.5 hours)
- Safety of the procedure(single-study visit of a duration of approximatively 2.5 hours)