Status:
RECRUITING
US Benchmarking Clinical Study
Lead Sponsor:
eMyosound SAS
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
HFpEF - Heart Failure With Preserved Ejection Fraction
HFmrEF
Eligibility:
All Genders
60+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07215715
Start Date
September 16 2025
End Date
July 1 2026
Last Update
October 20 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02116
3
Boston Medical Center
Boston, Massachusetts, United States, 02118