The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT)

The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplantation; Comorbidities and Coexisting Conditions

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital - Rigshospitalet
  • Odense, Denmark
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All liver transplanted individuals in Danmark.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Depression	Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key. When MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression). Mild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher	Baseline cross sectional data
Change in Depression	Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key. When MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression). Mild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher	10 years follow-up
Fracture risk	FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors. The FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture).	Baseline cross sectional data
Change in Fracture risk	FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors. The FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture).	10 year follow-up
Obstructive pulmonary disease	Nitric oxide in exhaled breath	Baseline cross sectional data
Obstructive pulmonary disease	Change in Nitric oxide in exhaled breath	10 year follow-up
Prevalence of Peripheral artery disease	Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.	Baseline cross sectional data
Change in Peripheral artery disease	Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.	10 years follow-up

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Susanne D Rasmussen, Professor, MD, DMSc, Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet; Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2043

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Sponsor1 - Rigshospitalet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No