Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT06253104
Status
Recruiting
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Conditions

  • Cardiogenic Shock
  • Heart Failure
  • Muscle Atrophy
  • Skeletal Muscle Atrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • BodyMetrix Body Composition Ultrasound — DIAGNOSTIC_TEST
    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.

Study Details

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 Dates

Start date
Feb 19, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Study Cohort
    All enrolled participants with no randomization group allocations

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Olivia Lovegreen
[email protected]
617-636-5000
Amanda R Vest, MBBS

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Tufts Medical Center· Boston, MA

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