Body Composition Ultrasound for Patients With Heart Failure

NCT ID: NCT03948776

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

Adults without HF or prior heart transplantation

BodyMetrix body composition ultrasound

Intervention Type: 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.

Participants in our existing LVAD body composition study

Currently-enrolled LVAD body composition participants, who chose to participate in this study on the same day as a DXA scan already scheduled for study #12026

BodyMetrix body composition ultrasound

Intervention Type: 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.

Patients with heart failure, an LVAD or heart transplantation

Any patients with a current diagnosis of HF, with or without an LVAD, or prior HF now status post heart transplantation

BodyMetrix body composition ultrasound

Intervention Type: 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.

Inpatients with heart failure, LVAD, heart transplantation

Patients with a current diagnosis of HF, with or without an LVAD, or prior HF now status post heart transplantation, currently admitted as inpatients at Tufts Medical Center. The 6/20/2019 protocol update includes these patients who will participate without a DXA scan (which can only be performed as an outpatient).

BodyMetrix body composition ultrasound only

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda R Vest, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Perkisas S, Baudry S, Bauer J, Beckwee D, De Cock AM, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Marco E, Merello A, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Cruz-Jentoft A, Vandewoude M. Application of ultrasound for muscle assessment in sarcopenia: towards standardized measurements. Eur Geriatr Med. 2018 Dec;9(6):739-757. doi: 10.1007/s41999-018-0104-9. Epub 2018 Sep 17.

Reference Type: BACKGROUND

PMID: 34674473 (View on PubMed)

Abe T, Fujita E, Thiebaud RS, Loenneke JP, Akamine T. Ultrasound-Derived Forearm Muscle Thickness Is a Powerful Predictor for Estimating DXA-Derived Appendicular Lean Mass in Japanese Older Adults. Ultrasound Med Biol. 2016 Sep;42(9):2341-4. doi: 10.1016/j.ultrasmedbio.2016.05.008. Epub 2016 Jun 17.

Reference Type: BACKGROUND

PMID: 27321173 (View on PubMed)

Abe T, Loenneke JP, Young KC, Thiebaud RS, Nahar VK, Hollaway KM, Stover CD, Ford MA, Bass MA, Loftin M. Validity of ultrasound prediction equations for total and regional muscularity in middle-aged and older men and women. Ultrasound Med Biol. 2015 Feb;41(2):557-64. doi: 10.1016/j.ultrasmedbio.2014.09.007. Epub 2014 Nov 25.

Reference Type: BACKGROUND

PMID: 25444689 (View on PubMed)

Takai Y, Ohta M, Akagi R, Kato E, Wakahara T, Kawakami Y, Fukunaga T, Kanehisa H. Applicability of ultrasound muscle thickness measurements for predicting fat-free mass in elderly population. J Nutr Health Aging. 2014;18(6):579-85. doi: 10.1007/s12603-013-0419-7.

Reference Type: BACKGROUND

PMID: 24950147 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13206

Identifier Type: -

Identifier Source: org_study_id