Recruiting

Observational Study

Sponsor:

Tufts Medical Center

Code:

NCT06253104

Conditions

Heart Failure

Muscle Atrophy

Skeletal Muscle Atrophy

Cardiogenic Shock

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BodyMetrix Body Composition Ultrasound

Study Details

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.

Conditions

Heart Failure

Muscle Atrophy

Skeletal Muscle Atrophy

Cardiogenic Shock

Study ID

NCT06253104

Start date

Feb 19, 2024

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Cohort

All enrolled participants with no randomization group allocations

Interventions

BodyMetrix 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.

Primary outcome measure

  • Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness [ Time Frame: 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) ]
  • Percentage change in skeletal muscle thickness after advanced therapies [ Time Frame: 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) ]
  • Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Amanda R Vest, MBBS

617-636-8068avest@tuftsmedicalcenter.org

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Olivia Lovegreen

617-636-5000OLovegreen@tuftsmedicalcenter.org

More Information

Sponsor

Tufts Medical Center

Last update posted

Apr 23, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-04-23.