End Stage Liver DIseaseNCT05477277
Adverse Outcomes and Mortality in Liver Transplant
A study testing MAsS in people with End Stage Liver DIsease and Sarcopenia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver DIsease, Sarcopenia, Sarcopenic Obesity
- What is being tested?
- MAsS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with end-stage liver disease undergoing evaluation for liver transplantation
- Patient clinically indicated for MRI during transplant candidacy evaluation
- Adult
Who cannot join
- 1. Contra indication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85259
Elizabeth Carey, MD, 480-342-1094
About this study
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.
Read the 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.
- Conditions
- End Stage Liver DIsease, Sarcopenia, Sarcopenic Obesity, Cirrhosis
- Being tested
- MAsS
- Medical subject headings
- End Stage Liver Disease, Sarcopenia, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAsSDiagnostic test
Add MAsS to standard of care MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes | Experimental | Not described Receives: Diagnostic Test: MAsS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle assessment score (MAsS)
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)
Measured: 1 year
Adverse outcomes
Number of pre- and post-transplant inpatient days
Measured: 1 year
Adverse outcomes
Number of pre- and post-transplant ICU days
Measured: 1 year
Adverse outcomes
Number of days alive outside of the hospital in the first year after liver transplant
Measured: 1 year
Adverse outcomes
Mortality within the first year after liver transplant
Measured: 1 year
MAsS changes while waiting for liver transplant
In patients who remain on the waitlist, serial MAsS measurements (see Outcome 1) will be taken and changes over time will be assessed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start2 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Amra Medical AB
- Responsible party
- Principal investigator, Elizabeth Carey, Mayo Clinic
- Investigators
- Elizabet Carey, MD, Principal investigator, Mayo Cinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477277
- Sponsor's protocol ID
- 21-007442
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2.
PubMed 26768490Borga M, West J, Bell JD, Harvey NC, Romu T, Heymsfield SB, Dahlqvist Leinhard O. Advanced body composition assessment: from body mass index to body composition profiling. J Investig Med. 2018 Jun;66(5):1-9. doi: 10.1136/jim-2018-000722. Epub 2018 Mar 25.
PubMed 29581385Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19.
PubMed 31220351Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x.
PubMed 16539636Flores A, Asrani SK. The donor risk index: A decade of experience. Liver Transpl. 2017 Sep;23(9):1216-1225. doi: 10.1002/lt.24799.
PubMed 28590542Karlsson A, Rosander J, Romu T, Tallberg J, Gronqvist A, Borga M, Dahlqvist Leinhard O. Automatic and quantitative assessment of regional muscle volume by multi-atlas segmentation using whole-body water-fat MRI. J Magn Reson Imaging. 2015 Jun;41(6):1558-69. doi: 10.1002/jmri.24726. Epub 2014 Aug 11.
PubMed 25111561Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22.
PubMed 29785727Linge J, Heymsfield SB, Dahlqvist Leinhard O. On the Definition of Sarcopenia in the Presence of Aging and Obesity-Initial Results from UK Biobank. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):1309-1316. doi: 10.1093/gerona/glz229.
PubMed 31642894Linge J, Ekstedt M, Dahlqvist Leinhard O. Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD. JHEP Rep. 2020 Oct 28;3(1):100197. doi: 10.1016/j.jhepr.2020.100197. eCollection 2021 Feb.
PubMed 33598647Linge J, Petersson M, Forsgren MF, Sanyal AJ, Dahlqvist Leinhard O. Adverse muscle composition predicts all-cause mortality in the UK Biobank imaging study. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1513-1526. doi: 10.1002/jcsm.12834. Epub 2021 Oct 29.
PubMed 34713982Montano-Loza AJ, Angulo P, Meza-Junco J, Prado CM, Sawyer MB, Beaumont C, Esfandiari N, Ma M, Baracos VE. Sarcopenic obesity and myosteatosis are associated with higher mortality in patients with cirrhosis. J Cachexia Sarcopenia Muscle. 2016 May;7(2):126-35. doi: 10.1002/jcsm.12039. Epub 2015 Jun 9.
PubMed 27493866Shenvi SD, Taber DJ, Hardie AD, Botstein JO, McGillicuddy JW. Assessment of magnetic resonance imaging derived fat fraction as a sensitive and reliable predictor of myosteatosis in liver transplant recipients. HPB (Oxford). 2020 Jan;22(1):102-108. doi: 10.1016/j.hpb.2019.06.006. Epub 2019 Aug 9.
PubMed 31405777West J, Dahlqvist Leinhard O, Romu T, Collins R, Garratt S, Bell JD, Borga M, Thomas L. Feasibility of MR-Based Body Composition Analysis in Large Scale Population Studies. PLoS One. 2016 Sep 23;11(9):e0163332. doi: 10.1371/journal.pone.0163332. eCollection 2016.
PubMed 27662190West J, Romu T, Thorell S, Lindblom H, Berin E, Holm AS, Astrand LL, Karlsson A, Borga M, Hammar M, Leinhard OD. Precision of MRI-based body composition measurements of postmenopausal women. PLoS One. 2018 Feb 7;13(2):e0192495. doi: 10.1371/journal.pone.0192495. eCollection 2018.
PubMed 29415060
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Outcomes and Mortality in Liver Transplant
- ClinicalTrials.gov ID
- NCT05477277
- Acronym / sponsor ID
- 21-007442
- Conditions
- End Stage Liver DIsease, Sarcopenia, Sarcopenic Obesity, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Amra Medical AB
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes | Experimental | Diagnostic Test: MAsS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with end-stage liver disease undergoing evaluation for liver transplantation
- Patient clinically indicated for MRI during transplant candidacy evaluation
- Adult
Key exclusion criteria (1 listed)
- 1. Contra indication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAsSAdd MAsS to standard of care MRI scan | Diagnostic test | Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes |
Primary outcome
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)
Adverse outcomes
Time frame: 1 year
Number of pre- and post-transplant inpatient days
Adverse outcomes
Time frame: 1 year
Number of pre- and post-transplant ICU days
Adverse outcomes
Time frame: 1 year
Number of days alive outside of the hospital in the first year after liver transplant
Adverse outcomes
Time frame: 1 year
Mortality within the first year after liver transplant
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 26768490Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2.
- Background: PubMed 29581385Borga M, West J, Bell JD, Harvey NC, Romu T, Heymsfield SB, Dahlqvist Leinhard O. Advanced body composition assessment: from body mass index to body composition profiling. J Investig Med. 2018 Jun;66(5):1-9. doi: 10.1136/jim-2018-000722. Epub 2018 Mar 25.
- Background: PubMed 31220351Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19.
- Background: PubMed 16539636Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x.
- Background: PubMed 28590542Flores A, Asrani SK. The donor risk index: A decade of experience. Liver Transpl. 2017 Sep;23(9):1216-1225. doi: 10.1002/lt.24799.
- Background: PubMed 25111561Karlsson A, Rosander J, Romu T, Tallberg J, Gronqvist A, Borga M, Dahlqvist Leinhard O. Automatic and quantitative assessment of regional muscle volume by multi-atlas segmentation using whole-body water-fat MRI. J Magn Reson Imaging. 2015 Jun;41(6):1558-69. doi: 10.1002/jmri.24726. Epub 2014 Aug 11.
- Background: PubMed 29785727Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22.
- Background: PubMed 31642894Linge J, Heymsfield SB, Dahlqvist Leinhard O. On the Definition of Sarcopenia in the Presence of Aging and Obesity-Initial Results from UK Biobank. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):1309-1316. doi: 10.1093/gerona/glz229.
- Background: PubMed 33598647Linge J, Ekstedt M, Dahlqvist Leinhard O. Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD. JHEP Rep. 2020 Oct 28;3(1):100197. doi: 10.1016/j.jhepr.2020.100197. eCollection 2021 Feb.
- Background: PubMed 34713982Linge J, Petersson M, Forsgren MF, Sanyal AJ, Dahlqvist Leinhard O. Adverse muscle composition predicts all-cause mortality in the UK Biobank imaging study. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1513-1526. doi: 10.1002/jcsm.12834. Epub 2021 Oct 29.
- Background: PubMed 27493866Montano-Loza AJ, Angulo P, Meza-Junco J, Prado CM, Sawyer MB, Beaumont C, Esfandiari N, Ma M, Baracos VE. Sarcopenic obesity and myosteatosis are associated with higher mortality in patients with cirrhosis. J Cachexia Sarcopenia Muscle. 2016 May;7(2):126-35. doi: 10.1002/jcsm.12039. Epub 2015 Jun 9.
- Background: PubMed 31405777Shenvi SD, Taber DJ, Hardie AD, Botstein JO, McGillicuddy JW. Assessment of magnetic resonance imaging derived fat fraction as a sensitive and reliable predictor of myosteatosis in liver transplant recipients. HPB (Oxford). 2020 Jan;22(1):102-108. doi: 10.1016/j.hpb.2019.06.006. Epub 2019 Aug 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabet Carey, MD principal investigator
Mayo Cinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAsS in people with End Stage Liver DIsease and Sarcopenia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Latasha Bunkley (480.342.5756, bunkley.latasha@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle assessment score (MAsS) (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477277, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.