RecruitingRecruiting
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
NCT06253104 · Tufts Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The investigators will be recruiting subjects with advanced cardiomyopathy in cardiogenic shock in the inpatient setting. This is an observational study to better understand changes in lean body mass during critical illness through a quick, safe, and non-invasive method. This study will also validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting, in the cardiogenic shock population.
The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Baseline US muscle thickness assessments will occur at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death). Each measurement session will take about 20-30 minutes.The investigators will take measurements at two sites: the lateral thigh and bicep (participant's dominant side). Clear ultrasound gel will be applied to the skin and the ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position.
The US images are read after a study visit completion, with measurements taken at pre-specified anatomic landmarks to obtain the muscle thickness, which is averaged accross the duplicate measurements. The primary endpoints are: Percentage change in skeletal muscle thickness from admission to nadir; Percentage change in skeletal muscle thickness after advanced therapies; and the Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes.
Eligibility criteria
Inclusion Criteria:
1. Over 18 years of age
2. Ejection fraction \<40%
3. Cardiogenic shock defined by clinical criteria (including any of: lactate \>2.5 mmol/L, systolic blood pressure \<90 mmHg, acute kidney or liver injury, or cardiac index \<2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)
Exclusion Criteria:
1. History of LVAD or other durable ventricular assist device
2. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke
3. Chronic enteric and parenteral nutrition support patients
Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-02-19
Estimated completion: 2026-12-31
Last updated: 2025-04-23
Interventions
Diagnostic Test: BodyMetrix Body Composition Ultrasound
Primary outcomes
- • Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness (Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (until discharge or death))
- • Percentage change in skeletal muscle thickness after advanced therapies (Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (until discharge or death))
- • Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes (Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death))
Sponsor
Tufts Medical Center · other
Contacts & investigators
ContactAmanda R Vest, MBBS · contact · avest@tuftsmedicalcenter.org · 617-636-8068
All locations (1)
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States