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New ultrasound method could spot muscle wasting in heart failure patients

NCT ID NCT03948776

Diagnosis Sponsor: Tufts Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks if a portable ultrasound device can accurately measure muscle and fat loss in people with heart failure. Researchers compared ultrasound results to the standard DXA scan in 48 participants, including healthy volunteers and heart failure patients. If validated, this ultrasound could offer a safer, cheaper, and more accessible way to diagnose muscle wasting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a simple, radiation-free way to diagnose muscle wasting in heart failure patients at the bedside.
What could go wrong
This is a small, early validation study with only 48 participants. The ultrasound may not match DXA accuracy, and results may not apply to all heart failure patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

48 people

The number who actually took part.

Started

May 2019

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Three study populations will be recruited for this observational validation study: Cohort 1: Healthy volunteers Cohort 2: Participants in our existing left ventricular assist device (LVAD) body composition study (#12026) who consent to undergo skeletal muscle ultrasound the same day as an LVAD body composition study visit that already includes the DXA and handgrip strength procedures Cohort 3: Patients with heart failure, an LVAD or heart transplantation Cohort 4: Inpatients with heart failure, an LVAD or heart transplantation, currently admitted to Tufts Medical Center

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Cohort 1: Healthy volunteers: * 18+ years * No history of heart failure * Not pregnant * Willing to take a urinary pregnancy test if there is a possibility of pregnancy * Able to freely provide informed consent 2. Cohort 2: Participants in our existing left ventricular assist device (LVAD) body composition study (#12026) who consent to undergo skeletal muscle ultrasound the same day as an LVAD body composition study visit that already includes the DXA and handgrip strength procedures: • Meet the eligibility criteria outlined in study #12026 3. Cohort 3: Patients with heart failure, an LVAD or heart transplantation * 18+ years * Not pregnant * Willing to take a urinary pregnancy test if there is a possibility of pregnancy Exclusion Criteria: 1. Patients requiring temporary mechanical circulatory support 2. Pregnant women, or women who report there is a possibility they could be pregnant and decline to complete a pregnancy test

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.