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DACOLT
Sponsor study identifier
observational
600
1 country
4
Study Start
March 15, 2021
Actual (reported)Primary Completion
January 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2043
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2043
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2021
Actual (reported)March 2, 2021
Actual (reported)March 15, 2021
Actual (reported)January 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2043
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
All liver transplanted individuals in Danmark.
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense, Denmark
Suarez-Zdunek MA, Bock A, Schultz NA, Kuhl JT, Villadsen GE, Fialla AD, Hansen JB, Krohn PS, Emde KU, Kirkby NS, Kober L, Knudsen AD, Kofoed KF, Nielsen SD. Cytomegalovirus infection and coronary artery disease in liver transplant recipients: Nationwide study using protocolized cardiac computed tomography. Int J Infect Dis. 2026 Aug;169:108785. doi: 10.1016/j.ijid.2026.108785. Epub 2026 May 12.
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 Jun 9;87(22):3077-3092. doi: 10.1016/j.jacc.2026.01.041. Epub 2026 Mar 4.
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.
Susanne D Rasmussen, Professor, MD, DMSc
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Allan Rasmussen, MD
Department of Transplantation and Digestive Diseases, Copenhagen University Hospital - Rigshospitalet
Klaus F Kofoed, Professor, MD, PhD, DMSc
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet
Tor Biering-Sørensen, Professor, MD, MSc, PhD
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
600 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2021
First Posted
March 2, 2021
Study Start
March 15, 2021
Actual (reported)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
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
January 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2043
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 21, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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