Observational Study of Muscle Changes in Heart Failure
This study looks at how muscle thickness changes in people with acute heart failure and cardiogenic shock (a severe form of heart failure where your heart can't pump enough blood). Researchers will use a special ultrasound device called BodyMetrix Body Composition Ultrasound to measure muscle thickness in your thigh and arm. They want to understand how muscle mass changes during critical illness and if this ultrasound can be a good way to measure these changes. You might be able to join if you are 18 to 100 years old, have an ejection fraction (a measure of how well your heart pumps blood) less than 40%, and are experiencing cardiogenic shock. The study will track changes in muscle thickness from when you're admitted to the hospital until you're discharged or pass away.
- Study design
- This is an observational study, meaning researchers will watch and record information without giving any specific treatments. It plans to enroll 60 participants.
- What's involved
- You would have ultrasound measurements taken at your bedside after consent, then on days 3 and 7, and every 7 days after that until you leave the hospital or pass away. Each measurement session will take about 20-30 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Muscle thickness will be measured until the end of your hospital stay (discharge or death).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
At a glance
Conditions
NCT06253104
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Tufts Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Percentage change in skeletal muscle thickness from admission to nadir of muscle thicknessImages 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)
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.
- Percentage change in skeletal muscle thickness after advanced therapiesImages 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)
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.
- Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomesImages 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)
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.