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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Recruitingn/aAges 18 Years - 100 YearsAllTufts Medical Center
NCT06253104 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • BodyMetrix Body Composition Ultrasound
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Where

1 site
Tufts Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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