The Danish Comorbidity in Liver Transplant Recipients Study

NCT04777032 | Active Not Recruiting DMC

• 1 other identifier: Sponsor1 - Rigshospitalet
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

Background: Liver transplantation is the only curative treatment for patients with end-stage liver disease. Short-term survival has improved due to improved surgical techniques and greater efficacy of immunosuppressive drugs. At present, the 10-year survival after liver transplantation is 60%, but long-term survival has not improved to the same extent the short-term survival. In addition to liver- and transplant-related causes, comorbidities such as cardiovascular, pulmonary, renal, and metabolic diseases have emerged as leading causes of morbidity and mortality in liver transplant recipients. The objective of this study is to assess the burden of comorbidities and identify both liver- and transplant-related risk factors as well as traditional risk factors that contribute to the pathogenesis of comorbidity in liver transplant recipients. Methods/design: The DACOLT study is an observational, longitudinal study. The investigators aim to include all adult liver transplant recipients in Denmark. Participants will be matched by sex and age to controls from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS). Physical and biological measures including blood pressure, ancle-brachial index, spirometry, exhaled nitric oxide, electrocardiogram, transthoracic echocardiography, computed tomography (CT) angiography of the heart, unenhanced CT of chest and abdomen and blood samples will be collected using uniform protocols in participants in CGPS, CCHS and DACOLT. Blood samples will be collected and stored in a research biobank. Follow-up examinations at regular intervals up to 10 years of follow-up are planned. Discussion: There is no international consensus standard for optimal clinical care or monitoring of liver transplant recipients. The study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on screening and long-term treatment and thereby contribute to improvement of the long-term survival.

Conditions

Comorbidities and Coexisting Conditions; Liver Transplantation

Outcome Measures

Primary Outcomes (18)

• Prevalence of coronary artery disease

  Assessed by coronary CT angiography

  Baseline cross-sectional data

• Change in Coronary artery disease

  Assessed by coronary CT angiography

  10 years follow-up

• Cardiac function

  Determined by transthoracic echocardiography

  Baseline cross-sectional data

• Change in Cardiac function

  Determined by transthoracic echocardiography

  10 years follow-up

• Cardiac structure

  Determined by transthoracic echocardiography

  Baseline cross-sectional data

• Change in cardiac structure

  Determined by transthoracic echocardiography

  10 years follow-up

• Cardiac structure

  Assessed by cardiac computed tomography (CT)

  Baseline cross-sectional data

• Change in Cardiac structure

  Assessed by cardiac computed tomography (CT)

  10 years follow-up

• Cardiac function

  Assessed by cardiac computed tomography (CT)

  Baseline cross-sectional data

• Change in Cardiac function

  Assessed by cardiac computed tomography (CT)

  10 years follow-up

• Dynamic lung function indices assessed by spirometry

  FVC and FEV1 assessed by spirometry

  Baseline cross-sectional data

• Change in Dynamic lung function indices assessed by spirometry

  FVC and FEV1 assessed by spirometry

  10 years follow-up

• Renal function

  Estimated glomerular filtration rate

  Baseline cross-sectional data

• Change in Renal function

  Estimated glomerular filtration rate

  10 years follow-up

• Metabolic diseases

  Prevalence of Diabetes

  Baseline cross-sectional data

• Metabolic diseases

  Change in Diabetes

  10 years follow-up

• Metabolic diseases

  Prevalence of Dyslipidaemia

  Baseline cross-sectional data

• Metabolic diseases

  Change in Dyslipidaemia

  10 years follow-up

Secondary Outcomes (8)

• Prevalence of Depression

  Baseline cross sectional data

• Change in Depression

  10 years follow-up

• Fracture risk

  Baseline cross sectional data

• Change in Fracture risk

  10 year follow-up

• Obstructive pulmonary disease

  Baseline cross sectional data

Study Arms (3)

Liver transplant recipients

All liver transplant recipient in Denmark aged 20-100 years will be eligible for inclusion in the DACOLT study. Inclusion requires the individual to be able to understand the study information in either Danish or English and to be able to provide an informed consent.

Control group 1_CGPS

The Copenhagen General Population Study (CGPS) is an ongoing observational population study with more than 110.000 participants from the greater Copenhagen area. All residents in the greater Copenhagen area \> 40 years and 25% of 20-40 years old are invited to participate in the study and in follow-up examinations every decade. A random sample of 10.000 participants aged ≥ 40 years had a contrast enhanced CT of the chest including CT angiography of the heart performed. Of these, 6500 had a contrast enhanced CT of the abdomen.

Control group 1_CCHS

The Copenhagen City Heart Study (CCHS) includes a random population sample included from the greater Copenhagen area. Health surveys have been repeated 5 times between 1976 and 2015. Almost 4000 participants were randomly selected for echocardiography.

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All liver transplanted individuals in Danmark.

You may qualify if:

• Liver transplanted
• age between 20 and 100 years
• be able to understand the study information in either Danish or English and to be able to provide an informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (4)

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (3)

• Knudsen AD, Kuhl JT, Schultz NA, Villadsen GE, Hogh J, Arentoft N, Suarez-Zdunek MA, Bock A, Fialla AD, Hansen JB, Krohn PS, Nordestgaard BG, Kober LV, Larsen AF, Pham MHC, Sigvardsen PE, Afzal S, Kofoed KF, Rasmussen A, Nielsen SD. Coronary Atherosclerosis in Liver Transplant Recipients and Population Controls: A Nationwide Study Using Protocolized CT Angiography. J Am Coll Cardiol. 2026 Mar 4:S0735-1097(26)00207-X. doi: 10.1016/j.jacc.2026.01.041. Online ahead of print.

  PMID: 41778959 DERIVED

• Suarez-Zdunek MA, Arentoft NS, Krohn PS, Lauridsen EHE, Afzal S, Hogh J, Thomsen MT, Knudsen AD, Nordestgaard BG, Hillingso JG, Villadsen GE, Holland-Fischer P, Rasmussen A, Fialla AD, Feldt-Rasmussen U, Nielsen SD. Prevalence of hyperthyroidism and hypothyroidism in liver transplant recipients and associated risk factors. Sci Rep. 2024 Apr 3;14(1):7828. doi: 10.1038/s41598-024-58544-3.

  PMID: 38570629 DERIVED

• Thomsen MT, Hogh J, Knudsen AD, Jensen AMR, Gelpi M, Villadsen GE, Abazi R, Holland-Fischer P, Kober L, Clemmesen O, Krohn PS, Hillingso J, Vilsboll T, Biering-Sorensen T, Kofoed KF, Nordestgaard BG, Rasmussen A, Nielsen SD. The Danish comorbidity in liver transplant recipients study (DACOLT): a non-interventional prospective observational cohort study. BMC Gastroenterol. 2021 Apr 1;21(1):145. doi: 10.1186/s12876-021-01733-5.

  PMID: 33794793 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biochemical analyses including fasting insulin and fasting blood glucose. Blood will be collected for a research biobank, and peripheral blood mononuclear cells, serum and plasma will be stored for further analyses of inflammation markers (chemokines, cytokines, soluble surface markers), coagulation markers (standard and functional platelet aggregation test), simulation assays and flowcytometry of PBMC, endothelial function markers (asymmetric dimethylarginine (ADMA), syndecan-1, trombomodulin and sE-selectin), markers of microbial translocation and bacterial degradation (sCD14, lipopolysaccharide, trimethylamine N-oxide), markers of lung tissue (alpha-1-antitrypsine, endothelin-1), liver markers (hyaluronic acid and fibrosis markers) and metabolomics and multiomics.

Study Officials

• Susanne D Rasmussen, Professor, MD, DMSc

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Allan Rasmussen, MD

  Department of Transplantation and Digestive Diseases, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Klaus F Kofoed, Professor, MD, PhD, DMSc

  Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Tor Biering-Sørensen, Professor, MD, MSc, PhD

  Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMSc

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 2, 2021
• Study Start: March 15, 2021
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2043
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

DK (4)