Heart Failure Clinical Trial
Official title:
Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in Patients With Heart Failure
NCT number | NCT03948776 |
Other study ID # | 13206 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 24, 2019 |
Est. completion date | December 31, 2023 |
Verified date | March 2024 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 | Completed |
Enrollment | 48 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Handgrip strength | Average of 3 handgrip strength measurements in the dominant upper extremity | On study day 1 | |
Secondary | Sit-to-stand test | Time (in seconds) for the participant complete 5 sit-to-stands, starting in a seated position on a chair | On study day 1 |
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