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NCT Number: NCT05477277

Adverse Outcomes and Mortality in Liver Transplant

Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Phoenix, Arizona, 85259, United States

Location status: Recruiting

Location contact

Elizabeth Carey, MD

CONTACT

480-342-1094

About this study

Sarcopenia, characterized by the progressive loss of muscle volume and function, is a common and major complication in end-stage liver disease which significantly contributes to adverse outcomes and mortality as well as hampers successful outcomes for treatments such as liver transplant (LT). High resolution image-based techniques have been instrumental in furthering our understanding of body composition in sarcopenia specifically and human health in general. While several methods exist to evaluate body composition, imaging techniques, such as computed tomography (CT) and magnetic resonance imaging (MRI) enable capitalization of images taken as part of standard practice as well as append already clinical examinations with brief sequences tailored for mapping muscle and body composition. Opportunistic application of this imaging-based body composition assessment to patients in a liver transplant context has revealed a high prevalence of sarcopenia (low muscle volume relative to age and sex) and pathological muscle fat infiltration (myosteatosis). Furthermore, a recent long-term (6-years post-LT) MRI-based retrospective study showed associations of myosteatosis to increased graft loss and mortality after transplant.

The combination of MRI-based thigh muscle volume and fat infiltration has been suggested as a more complete description of muscle composition with a stronger link to hospitalization, poor functional activities of daily life, and metabolic co-morbidities in general population and subjects presenting with non-alcoholic fatty liver disease. A recently submit paper explored the predictive power of this combination based on 40 000 participants in the UK biobank and found that the presence of adverse muscle composition, that is the combination of lower-than-expected muscle volume and high muscle fat infiltration, showed to be a strong and independent predictor of all-cause mortality comparable to that of previous cancer diagnosis and smoking. The same MRI-sequence and body composition assessment has successfully been implemented in small pilot studies before and after LT, both within weeks and years after LT, and presented at recent scientific conferences.

There is a lack of knowledge in how to fully identity patients indicted for liver transplant that are of very high risk for adverse outcomes and mortality in standardized fashion. The aim is to use an MRI-based Muscle Assessment Score (MAsS), which includes both muscle volume and fat infiltration, at the transplant candidacy evaluation and other follow-up MRI examinations as clinically indicated, as an objective, standardized, and quantitative measure of muscle health and explore the link between muscle composition and adverse outcomes and mortality. In addition, there are growing numbers of high-risk donor livers, such as presenting with steatosis or exposed to prolonged ischemia time. A co-primary aim is to gather information on the association between transplant recipient muscle composition and donor liver characteristics to one-year post-LT adverse outcomes and mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with end-stage liver disease undergoing evaluation for liver transplantation
  • Patient clinically indicated for MRI during transplant candidacy evaluation
  • Adult

Exclusion criteria

  • Contra indication to MRI

Treatment and study plan

MAsS

Diagnostic Test

Add MAsS to standard of care MRI scan

Primary outcomes

  1. Muscle assessment score (MAsS)

    Time frame: 1 year

    The MAsS is a composite score of muscle fat index (% of muscle fat normalized to sex, weight in kg and height in meters) and muscle volume index (muscle volume in liters normalized to patient sex, height in meters and weight in kg)

  2. Adverse outcomes

    Time frame: 1 year

    Number of pre- and post-transplant inpatient days

  3. Adverse outcomes

    Time frame: 1 year

    Number of pre- and post-transplant ICU days

  4. Adverse outcomes

    Time frame: 1 year

    Number of days alive outside of the hospital in the first year after liver transplant

  5. Adverse outcomes

    Time frame: 1 year

    Mortality within the first year after liver transplant

  6. MAsS changes while waiting for liver transplant

    Time frame: 1 year

    In patients who remain on the waitlist, serial MAsS measurements (see Outcome 1) will be taken and changes over time will be assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Latasha Bunkley

CONTACT

[email protected]

480.342.5756

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Amra Medical AB

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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