US Benchmarking Clinical Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
eMyosound SAS
Study ID
NCT07215715
Status
Recruiting
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Conditions

  • ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
  • Cardiac Amyloidosis
  • HFmrEF
  • HFpEF - Heart Failure With Preserved Ejection Fraction
  • Left Ventricular Hypertrophy

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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)
  • Arm: Heart Failure with LVEF > 40% and LVH, without ATTR-CM
    Heart Failure with LVEF \> 40% and LVH, without ATTR-CM
  • Arm: Control group of patients without heart failure or cardiomyopathy
    Control group of patients without heart failure or cardiomyopathy.

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Denise M Fine
[email protected]
781-293-9146
Deepa M Gopal, M.D. (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02116
Sarah Cuddy, M.D.
[email protected]
863-303-6799
Sarah Cuddy, M.D. (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Hanna K Gaggin, M.D.
[email protected]
617-726-2709
Hanna K Gaggin, M.D. (PRINCIPAL_INVESTIGATOR)
Laura P Cohen, M.D. (SUB_INVESTIGATOR)
Anshul B Parulkar, M.D. (SUB_INVESTIGATOR)

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By research site
Boston Medical Center· Boston, MABrigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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