Actively Recruiting
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Led by Tufts Medical Center · Updated on 2025-04-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how skeletal muscle mass changes in patients with acute heart failure and cardiogenic shock who undergo advanced treatments like heart transplantation or left ventricular assist device implantation. This observational study aims to understand the timing and extent of muscle loss and how it relates to patient outcomes. It also evaluates the use of bedside ultrasound imaging to monitor muscle mass in hospitalized patients, providing insights into muscle wasting during critical illness. The study uses a BodyMetrix Pro ultrasound device to measure muscle thickness at the lateral thigh and bicep on the dominant or right side. Measurements are taken at baseline after consent, then on days 3 and 7, and weekly thereafter until the patient is discharged or passes away. This schedule repeats after advanced therapies like heart transplantation or device implantation. Each session lasts about 20 to 30 minutes and involves taking multiple images to assess muscle thickness. Participants will be inpatients with advanced cardiomyopathy and cardiogenic shock. Muscle thickness is measured repeatedly during their hospital stay, and results are analyzed to track changes over time and their relation to clinical outcomes. Additional assessments include a nutritional risk index and monitoring of hospital outcomes like mortality and length of stay. This study helps validate ultrasound as a practical tool to assess muscle wasting in this patient group.
CONDITIONS
Brief Title
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Ejection fraction less than 40%
- Cardiogenic shock defined by clinical criteria including lactate >2.5 mmol/L, systolic blood pressure <90 mmHg, acute kidney or liver injury, or cardiac index <2.1 on monitoring
- Clinical need for at least one pressor, inotrope, or temporary mechanical circulatory support device
You will not qualify if you...
- History of left ventricular assist device or other durable ventricular assist device use
- Clinical disorders causing skeletal muscle weakness or wasting such as muscular dystrophy, mitochondrial disorder, active cancer, or severe stroke disability
- Patients receiving chronic enteric or parenteral nutrition support
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From baseline after consent until discharge or death during the index hospitalization
Participants undergo ultrasound measurements of skeletal muscle thickness at the lateral thigh and bicep to assess body composition during cardiogenic shock.
1 baseline visit, then visits on days 3 and 7, followed by weekly visits until discharge or death
Duration - Duration of index hospitalization until discharge or death
Participants are observed for clinical outcomes related to muscle mass loss during cardiogenic shock and advanced therapies, including follow-up of hospitalization outcomes.
Observations occur alongside ultrasound measurement visits until discharge or death
Trial Site Locations
Total: 1 location
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
A
Amanda R Vest, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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