Clinical trial NCT06253104: Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Official title: Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Muscle Atrophy
Skeletal Muscle Atrophy
Cardiogenic Shock
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with 1) advanced heart failure and 2) who have been admitted to the hospital, will be recruited from inpatient cardiology floors.

Brief 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.

Detailed description: The investigators will be recruiting subjects with advanced cardiomyopathy in cardiogenic shock in the inpatient setting. This is an observational study to better understand changes in lean body mass during critical illness through a quick, safe, and non-invasive method. This study will also validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting, in the cardiogenic shock population.

The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Baseline US muscle thickness assessments will occur 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). Each measurement session will take about 20-30 minutes.The investigators will take measurements at two sites: the lateral thigh and bicep (participant's dominant side). Clear ultrasound gel will be applied to the skin and the ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position.

The US images are read after a study visit completion, with measurements taken at pre-specified anatomic landmarks to obtain the muscle thickness, which is averaged accross the duplicate measurements. The primary endpoints are: Percentage change in skeletal muscle thickness from admission to nadir; Percentage change in skeletal muscle thickness after advanced therapies; and the Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years of age
2. Ejection fraction \<40%
3. 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:

1. History of LVAD or other durable ventricular assist device
2. 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
3. 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.

Primary outcomes:
measure: Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness
timeFrame: Images 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)
measure: Percentage change in skeletal muscle thickness after advanced therapies
timeFrame: Images 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)
measure: Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes
timeFrame: Images 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)
Secondary outcomes:
measure: Geriatric nutritional risk index (GNRI)
timeFrame: Once at baseline
measure: Upper extremity versus lower extremity US muscle thickness decreases
timeFrame: Images 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)
measure: Inhospital mortality
timeFrame: Index Hospitalization
measure: Post-LVAD/HT length of stay
timeFrame: Index Hospitalization
measure: Discharge to a rehabilitation facility versus home
timeFrame: Conclusion of index Hospitalization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: