Body Composition Ultrasound for Patients With Heart Failure

NCT03948776 | Completed FDA Device

• 1 other identifier: 13206
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

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

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

  On study day 1

• Primary ultrasound endpoint: FFM measured by BodyMetrix ultrasound

  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

  On study day 1

Secondary Outcomes (2)

• Handgrip strength

  On study day 1

• Sit-to-stand test

  On study day 1

Study Arms (4)

Healthy volunteers

Adults without HF or prior heart transplantation

Diagnostic Test: BodyMetrix body composition ultrasound

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

Diagnostic Test: BodyMetrix body composition ultrasound

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

Diagnostic Test: BodyMetrix body composition ultrasound

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).

Diagnostic Test: BodyMetrix body composition ultrasound only

Interventions

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.

Healthy volunteers; Participants in our existing LVAD body composition study; Patients with heart failure, an LVAD or heart transplantation

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.

Inpatients with heart failure, LVAD, heart transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Cohort 1: Healthy volunteers:
• + 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
• + years
• Not pregnant
• Willing to take a urinary pregnancy test if there is a possibility of pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• 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.

  PMID: 34674473 BACKGROUND

• 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.

  PMID: 27321173 BACKGROUND

• 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.

  PMID: 25444689 BACKGROUND

• 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.

  PMID: 24950147 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Amanda R Vest, MBBS, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: May 24, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)