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Life sciences · Observational Study
ClinicalTrials.gov · October 26, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06253104). This is a study registration, not published results. Lead sponsor: Tufts Medical Center. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Heart Failure, Muscle Atrophy, Skeletal Muscle Atrophy, Cardiogenic Shock. Interventions: DIAGNOSTIC_TEST: BodyMetrix Body Composition Ultrasound. Primary outcome measures: 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). Brief summary: This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.