NCT03948776Completed
Body Composition Ultrasound for Patients With Heart Failure
Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 48 (actual)
- First submitted
- 10 May 2019
- Start date
- 24 May 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Tufts Medical Center
- Diseases
- Heart failure
- NCT number
- NCT03948776
What you commit to
- Study type: Observational
- Participants enrolled: 48
- From 24 May 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.