Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Recruiting · NCT06253104 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tufts Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- 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
1 location listed across 1 US state.
- Tufts Medical Center - Boston, Massachusetts, United States