Clinical Trial

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-01; most recent amendment 2025-04-18.
Status change: Not Yet Recruiting → Recruiting 2024-02-22
Trial Details
NCT Number NCT06253104
Lead Sponsor Tufts Medical Center
Conditions Heart Failure, Muscle Atrophy, Skeletal Muscle Atrophy, Cardiogenic Shock
Enrollment 60 participants
Start Date 2024-02-19
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-23