An observational study in Heart Failure, Muscle Atrophy and Skeletal Muscle Atrophy, sponsored by Tufts Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Tufts Medical Center · Observational
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
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Patients with 1) advanced heart failure and 2) who have been admitted to the hospital, will be recruited from inpatient cardiology floors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants with no randomization group allocations
Diagnostic Test: BodyMetrix Body Composition Ultrasound
We will use a BodyMetrix Pro A-mode ultrasound device (BodyMetrix Pro, Intelametrix Inc., Livermore, CA) which is a lay imaging tool designed specifically to assess body composition. Images will be taken at two sites; the lateral thigh and bicep on the dominant side if able to identify, or else on the right side. On each visit, five images will be taken at each site (the lateral thigh and bicep). Participants will be measured 2-3 days from initiation in study, then 7 days after, and then weekly from the first measurement until time of advanced therapy, discharge, or death. This measurement sequence will then be repeated following advanced therapy up until discharge or death. Each measurement session will last about 20-30 minutes. This will be performed by the PI or members of the study team who have been trained by the research coordinator.
Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness
Quantify the percentage change in skeletal muscle thickness from admission to nadir of muscle thickness and describe the time course of muscle loss. We hypothesize that all patients will experience a decrease in skeletal muscle thickness in the days-to-weeks after admission, as indicated by change in skeletal muscle thickness on ultrasound, and anticipate the magnitude of this muscle thickness change to be in the range of -5%. This aim will be investigated in both patients who ultimately receive the HT or LVAD advanced therapies, and also those who do not.
Time frame: 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
Quantify the percentage change in skeletal muscle thickness achieved early after advanced therapies (LVAD/HT). We hypothesize that hospitalized patients with advanced heart failure will experience a minor muscle recovery during the hospital stay following advanced therapy surgeries, but not a recovery in the range of +5% which would likely require a 3-month follow-up period.
Time frame: 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
Evaluate the relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes. We hypothesize that a greater negative percent change in muscle thickness from admission to the nadir thickness value will be associated with higher inhospital mortality, and for those who receive an LVAD/HT a longer post-operative length of stay and greater probably of discharge to a rehabilitation facility as opposed to home.
Time frame: 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)
Geriatric nutritional risk index (GNRI)
Evaluating the association between malnutrition risk as assessed by geriatric nutritional risk index (GNRI) on admission and change in skeletal muscle thickness from admission to nadir.
Time frame: Once at baseline
Upper extremity versus lower extremity US muscle thickness decreases
Determine if an upper extremity or lower extremity US muscle site location for percentage change is most strongly associated with mortality and with GNRI on admission.
Time frame: 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)
Inhospital mortality
Occurence of mortality during index hospitalization
Time frame: Index Hospitalization
Post-LVAD/HT length of stay
Days from LVAD/HT surgery until discharge from hospital or death
Time frame: Index Hospitalization
Discharge to a rehabilitation facility versus home
Discharge destination at conclusion of index hospitalization
Time frame: Conclusion of index Hospitalization
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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