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US Benchmarking Clinical Study

NCT07215715 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-10-20

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Boston Medical Center

    collaborator OTHER

  • eMyosound SAS

    lead INDUSTRY

Principal Investigators

  • Thierry Sarda · eMyosound SAS

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215715 on ClinicalTrials.gov