NCT03948776

Body Composition Ultrasound for Patients With Heart Failure

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. For woman with child-bearing potential, potential participants will be required to undergo a urine pregnancy test prior to DXA imaging. 2. The investigators will record participant age, sex, height, weight and heart failure status. 3. 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. 4. 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. 5. Handgrip strength: this involves the participant squeezing a handheld machine on three occasions in the dominant hand to measure grip strength. 6. 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BodyMetrix body composition ultrasound	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.
DIAGNOSTIC_TEST	BodyMetrix body composition ultrasound only	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.

Timeline

• Start date: 2019-05-24
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-05-14
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study