Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Recruiting now

Conditions studied: Heart Failure, Muscle Atrophy, Skeletal Muscle Atrophy, Cardiogenic Shock

In brief

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.

Key facts

Study ID

NCT06253104

Run by

Tufts Medical Center

People needed

60

Starts

2024-02-19

Expected to finish

2026-12-31

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Over 18 years of age
• Ejection fraction <40%
• Cardiogenic shock defined by clinical criteria (including any of: lactate >2.5 mmol/L, systolic blood pressure <90 mmHg, acute kidney or liver injury, or cardiac index <2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)

You may not qualify if…

• History of LVAD or other durable ventricular assist device
• An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke
• Chronic enteric and parenteral nutrition support patients
• Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.