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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

NCT06253104 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-23

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06253104 on ClinicalTrials.gov