Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
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 Start (Actual) 19 February 2024
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 January 2024
  • First Submitted that Met QC Criteria 1 February 2024
  • First Posted 12 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 February 2024
  • Last Update Posted 26 February 2024
  • Last Verified February 2024