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NCT Number: NCT03948776

Body Composition Ultrasound for Patients With Heart Failure

This study aims to determine whether skeletal muscle ultrasound is a useful technique for measuring low muscle mass in patients with heart failure (HF). Muscle wasting and abnormal muscle quality has been identified in patients with advanced HF and may contribute to patients' physical limitations. However assessments of body composition for patients with HF currently rely on the research tool of dual X-ray absorptiometry (DXA) for measurements of skeletal muscle mass, which is limited by cost, use of radiation, and the need for patients to be transported to the DXA scanner for imaging. Therefore this observational study is designed to validate a new approach that allows a safe and portable assessment of body composition.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

The investigators will be recruiting both healthy subjects without HF, as well as subjects with either HF, a left ventricular assist device (LVAD) or cardiac transplantation. This is an observational study to validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting. The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Participation will last for only one day, with approximately 2 hours of study activity in total:

  • For woman with child-bearing potential, potential participants will be required to undergo a urine pregnancy test prior to DXA imaging.
  • The investigators will record participant age, sex, height, weight and heart failure status.
  • Muscle ultrasound: investigators will make measurements at 7 positions on the arm, chest wall, and leg (participant's dominant side). Clear ultrasound gel will be applied to the skin, a BodyMetrix ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position. The gel is then wiped away.
  • Whole body dual X-ray absorptiometry (DXA) scan: the DXA scan involves lying on a flat and open scanner for approximately 5 minutes while an X-ray arm passes over the body to form a picture for whole body composition.
  • Handgrip strength: this involves the participant squeezing a handheld machine on three occasions in the dominant hand to measure grip strength.
  • 5 sit-to-stand test: investigators will time how long it takes for the participant to stand up from a seated position five times to assess lower body strength.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • 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

  • Patients requiring temporary mechanical circulatory support
  • Pregnant women, or women who report there is a possibility they could be pregnant and decline to complete a pregnancy test

Treatment and study plan

BodyMetrix body composition ultrasound

Diagnostic Test

Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. These will be compared to the reference technique of whole-body DXA imaging.

BodyMetrix body composition ultrasound only

Diagnostic Test

Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. For inpatients currently admitted to the hospital, whole-body DXA imaging cannot be performed, as so the only assessment of body composition will be with the ultrasound.

Primary outcomes

  1. Primary DXA endpoint: fat free mass (FFM) measured by DXA

    Time frame: On study day 1

    This is the fat free mass calculated by whole-body DXA, which is the gold standard for measuring skeletal muscle mass

  2. Primary ultrasound endpoint: FFM measured by BodyMetrix ultrasound

    Time frame: On study day 1

    This is the muscle mass estimation from the BodyMetrix ultrasound device which the investigators are seeking to validate as a method of body composition assessment

Secondary outcomes

  1. Handgrip strength

    Time frame: On study day 1

    Average of 3 handgrip strength measurements in the dominant upper extremity

  2. Sit-to-stand test

    Time frame: On study day 1

    Time (in seconds) for the participant complete 5 sit-to-stands, starting in a seated position on a chair

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in Patients With Heart Failure

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 14, 2019
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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