Adverse Outcomes and Mortality in Liver Transplant

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05477277

Collaborator

Amra Medical AB (Industry)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver DIsease Sarcopenia Sarcopenic Obesity Cirrhosis	Diagnostic Test: MAsS	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Adverse Outcomes and Mortality in Liver Transplant

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes	Diagnostic Test: MAsS Add MAsS to standard of care MRI scan

Arm

Intervention/Treatment

Experimental: Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes

Diagnostic Test: MAsS

Add MAsS to standard of care MRI scan

Outcome Measures

Primary Outcome Measures

Muscle assessment score (MAsS) [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)
Adverse outcomes [1 year]
Number of pre- and post-transplant inpatient days
Adverse outcomes [1 year]
Number of pre- and post-transplant ICU days
Adverse outcomes [1 year]
Number of days alive outside of the hospital in the first year after liver transplant
Adverse outcomes [1 year]
Mortality within the first year after liver transplant
MAsS changes while waiting for liver transplant [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85259

Sponsors and Collaborators

Mayo Clinic
Amra Medical AB

Investigators

Principal Investigator: Elizabet Carey, MD, Mayo Cinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Elizabeth Carey, Professor of Medicine, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05477277

Other Study ID Numbers:

21-007442

First Posted:

Jul 28, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Liver Diseases

End Stage Liver Disease

Sarcopenia

Study Results

No Results Posted as of Aug 16, 2022