RecruitingNCT06253104

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure


Sponsor

Tufts Medical Center

Enrollment

60 participants

Start Date

Feb 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study examines changes in muscle size and strength in patients who are critically ill with cardiogenic shock (a life-threatening condition where the heart can't pump enough blood). Researchers use bedside ultrasound to measure muscle thickness over time, aiming to understand how quickly muscles deteriorate and how interventions might help. **You may be eligible if...** - You are 18 or older - Your heart's pumping function (ejection fraction) is below 40% - You are in cardiogenic shock requiring at least one medication or mechanical device to support your heart or blood pressure - You are in an acute care hospital setting **You may NOT be eligible if...** - You have had a ventricular assist device (heart pump) implanted long-term - You have a condition known to cause muscle weakness (such as muscular dystrophy, active cancer, or a severe prior stroke) - You are on long-term tube or IV feeding - You are on a breathing machine or have previously had a heart transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBodyMetrix 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.


Locations(1)

Tufts Medical Center

Boston, Massachusetts, United States

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NCT06253104


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