Assessing muscle thickness changes in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the changes in skeletal muscle mass in patients with acute heart failure undergoing advanced therapies like orthotropic heart transplantation and left ventricular assist device implantation. Using a non-invasive ultrasound method, the study will measure muscle thickness at specific anatomical sites during hospitalization to understand the relationship between muscle mass loss and patient outcomes. The study will also validate the use of a specific ultrasound device for assessing body composition in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Amanda R Vest, MBBS
• Email: avest@tuftsmedicalcenter.org
• Phone: 617-636-8068

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.