Adverse Outcomes and Mortality in Liver Transplant

NCT05477277 | Recruiting FDA Device

• 1 other identifier: 21-007442
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver DIsease; Sarcopenia; Sarcopenic Obesity; Cirrhosis

Outcome Measures

Primary Outcomes (6)

• 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)

  1 year

• Adverse outcomes

  Number of pre- and post-transplant inpatient days

  1 year

• Adverse outcomes

  Number of pre- and post-transplant ICU days

  1 year

• Adverse outcomes

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

  1 year

• Adverse outcomes

  Mortality within the first year after liver transplant

  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

  1 year

Study Arms (1)

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

EXPERIMENTAL

Diagnostic Test: MAsS

Interventions

MAsS DIAGNOSTIC_TEST

Add MAsS to standard of care MRI scan

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Contra indication to MRI

Sponsors & Collaborators

• Mayo Clinic: lead
• Amra Medical AB: collaborator

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85259, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 26768490 BACKGROUND

• Borga 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.

  PMID: 29581385 BACKGROUND

• Carey 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.

  PMID: 31220351 BACKGROUND

• Feng 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.

  PMID: 16539636 BACKGROUND

• Flores A, Asrani SK. The donor risk index: A decade of experience. Liver Transpl. 2017 Sep;23(9):1216-1225. doi: 10.1002/lt.24799.

  PMID: 28590542 BACKGROUND

• Karlsson 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.

  PMID: 25111561 BACKGROUND

• Linge 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.

  PMID: 29785727 BACKGROUND

• Linge 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.

  PMID: 31642894 BACKGROUND

• Linge 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.

  PMID: 33598647 BACKGROUND

• Linge 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.

  PMID: 34713982 BACKGROUND

• Montano-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.

  PMID: 27493866 BACKGROUND

• Shenvi 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.

  PMID: 31405777 BACKGROUND

• West 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.

  PMID: 27662190 BACKGROUND

• West 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.

  PMID: 29415060 BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease; Sarcopenia; Fibrosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Elizabet Carey, MD

  Mayo Cinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Latasha Bunkley

CONTACT

480.342.5756; bunkley.latasha@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 28, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)