Heart FailureNCT03948776
Body Composition Ultrasound for Patients With Heart Failure
An observational study of Heart Failure, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- BodyMetrix body composition ultrasound and BodyMetrix body composition ultrasound only
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in 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.
Read the 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:
- 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.
- Conditions
- Heart Failure
- Being tested
- BodyMetrix body composition ultrasound, BodyMetrix body composition ultrasound only
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyMetrix body composition ultrasoundDiagnostic 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 onlyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Adults without HF or prior heart transplantation Receives: 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 Receives: 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 Receives: 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). Receives: Diagnostic Test: BodyMetrix body composition ultrasound only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: On study day 1
Secondary outcomes (2)
Handgrip strength
Average of 3 handgrip strength measurements in the dominant upper extremity
Measured: On study day 1
Sit-to-stand test
Time (in seconds) for the participant complete 5 sit-to-stands, starting in a seated position on a chair
Measured: On study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start24 May 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda R Vest, MBBS, MPH, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948776
- Sponsor's protocol ID
- 13206
- Status last verified
- Jan 2026
- First submitted
- 10 May 2019
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34674473Abe 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.
PubMed 27321173Abe 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.
PubMed 25444689Takai 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.
PubMed 24950147
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03948776
- Acronym / sponsor ID
- 13206
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: BodyMetrix body composition ultrasoundAdults without HF or prior heart transplantation |
| Participants in our existing LVAD body composition study | – | Diagnostic Test: BodyMetrix body composition ultrasoundCurrently-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 |
| Patients with heart failure, an LVAD or heart transplantation | – | Diagnostic Test: BodyMetrix body composition ultrasoundAny patients with a current diagnosis of HF, with or without an LVAD, or prior HF now status post heart transplantation |
| Inpatients with heart failure, LVAD, heart transplantation | – | Diagnostic Test: BodyMetrix body composition ultrasound onlyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyMetrix body composition ultrasoundInvestigators 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 | Healthy volunteers, Participants in our existing LVAD body composition study, Patients with heart failure, an LVAD or heart transplantation |
| BodyMetrix body composition ultrasound onlyInvestigators 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. | Diagnostic test | Inpatients with heart failure, LVAD, heart transplantation |
Primary outcome
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
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
2 secondary outcomes
Handgrip strength
Time frame: On study day 1
Sit-to-stand test
Time frame: On study day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 34674473Perkisas 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.
- Background: PubMed 27321173Abe 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.
- Background: PubMed 25444689Abe 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.
- Background: PubMed 24950147Takai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda R Vest, MBBS, MPH principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary DXA endpoint: fat free mass (FFM) measured by DXA (time frame: On study day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948776, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.