Liver TransplantationDACOLTNCT04777032
The Danish Comorbidity in Liver Transplant Recipients Study
An observational study of Liver Transplantation and Comorbidities and Coexisting Conditions, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation, Comorbidities and Coexisting Conditions
- How many people
- 600 participants
- Where
- 4 sitesDenmark
- Study dates
- 15 Mar 2021to 1 Jan 2043
- Phase
- Observational
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All liver transplanted individuals in Danmark.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense
About this study
Official title: 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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of coronary artery disease
Assessed by coronary CT angiography
Measured: Baseline cross-sectional data
Change in Coronary artery disease
Assessed by coronary CT angiography
Measured: 10 years follow-up
Cardiac function
Determined by transthoracic echocardiography
Measured: Baseline cross-sectional data
Change in Cardiac function
Determined by transthoracic echocardiography
Measured: 10 years follow-up
Cardiac structure
Determined by transthoracic echocardiography
Measured: Baseline cross-sectional data
Change in cardiac structure
Determined by transthoracic echocardiography
Measured: 10 years follow-up
Cardiac structure
Assessed by cardiac computed tomography (CT)
Measured: Baseline cross-sectional data
Change in Cardiac structure
Assessed by cardiac computed tomography (CT)
Measured: 10 years follow-up
Cardiac function
Assessed by cardiac computed tomography (CT)
Measured: Baseline cross-sectional data
Change in Cardiac function
Assessed by cardiac computed tomography (CT)
Measured: 10 years follow-up
Dynamic lung function indices assessed by spirometry
FVC and FEV1 assessed by spirometry
Measured: Baseline cross-sectional data
Change in Dynamic lung function indices assessed by spirometry
FVC and FEV1 assessed by spirometry
Measured: 10 years follow-up
Renal function
Estimated glomerular filtration rate
Measured: Baseline cross-sectional data
Change in Renal function
Estimated glomerular filtration rate
Measured: 10 years follow-up
Metabolic diseases
Prevalence of Diabetes
Measured: Baseline cross-sectional data
Metabolic diseases
Change in Diabetes
Measured: 10 years follow-up
Metabolic diseases
Prevalence of Dyslipidaemia
Measured: Baseline cross-sectional data
Metabolic diseases
Change in Dyslipidaemia
Measured: 10 years follow-up
Secondary outcomes (8)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 10 year follow-up
Obstructive pulmonary disease
Nitric oxide in exhaled breath
Measured: Baseline cross sectional data
Obstructive pulmonary disease
Change in Nitric oxide in exhaled breath
Measured: 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.
Measured: 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.
Measured: 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start15 Mar 2021
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jan 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Dam Nielsen, MD, DMSc, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Susanne D Rasmussen, Professor, MD, DMSc, Principal investigator, Department of Infectious Diseases, Copenhagen University Hospital - RigshospitaletAllan Rasmussen, MD, Study director, Department of Transplantation and Digestive Diseases, Copenhagen University Hospital - RigshospitaletKlaus F Kofoed, Professor, MD, PhD, DMSc, Study director, Department of Cardiology, Copenhagen University Hospital - RigshospitaletTor Biering-Sørensen, Professor, MD, MSc, PhD, Study director, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777032
- Sponsor's protocol ID
- Sponsor1 - Rigshospitalet
- Acronym
- DACOLT
- Status last verified
- Jan 2026
- First submitted
- 16 Feb 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42119773Knudsen 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.
PubMed 41778959Suarez-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.
PubMed 38570629Thomsen 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.
PubMed 33794793
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04777032
- Acronym / sponsor ID
- DACOLT / Sponsor1 - Rigshospitalet
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jan 2043 (estimated)
- First posted
- 2 Mar 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All liver transplanted individuals in Danmark.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of coronary artery disease
Time frame: Baseline cross-sectional data
Assessed by coronary CT angiography
Change in Coronary artery disease
Time frame: 10 years follow-up
Assessed by coronary CT angiography
Cardiac function
Time frame: Baseline cross-sectional data
Determined by transthoracic echocardiography
Change in Cardiac function
Time frame: 10 years follow-up
Determined by transthoracic echocardiography
Cardiac structure
Time frame: Baseline cross-sectional data
Determined by transthoracic echocardiography
Change in cardiac structure
Time frame: 10 years follow-up
Determined by transthoracic echocardiography
Cardiac structure
Time frame: Baseline cross-sectional data
Assessed by cardiac computed tomography (CT)
Change in Cardiac structure
Time frame: 10 years follow-up
Assessed by cardiac computed tomography (CT)
Cardiac function
Time frame: Baseline cross-sectional data
Assessed by cardiac computed tomography (CT)
Change in Cardiac function
Time frame: 10 years follow-up
Assessed by cardiac computed tomography (CT)
Dynamic lung function indices assessed by spirometry
Time frame: Baseline cross-sectional data
FVC and FEV1 assessed by spirometry
Change in Dynamic lung function indices assessed by spirometry
Time frame: 10 years follow-up
FVC and FEV1 assessed by spirometry
Renal function
Time frame: Baseline cross-sectional data
Estimated glomerular filtration rate
Change in Renal function
Time frame: 10 years follow-up
Estimated glomerular filtration rate
Metabolic diseases
Time frame: Baseline cross-sectional data
Prevalence of Diabetes
Metabolic diseases
Time frame: 10 years follow-up
Change in Diabetes
Metabolic diseases
Time frame: Baseline cross-sectional data
Prevalence of Dyslipidaemia
Metabolic diseases
Time frame: 10 years follow-up
Change in Dyslipidaemia
8 secondary outcomes
Prevalence of Depression
Time frame: Baseline cross sectional data
Change in Depression
Time frame: 10 years follow-up
Fracture risk
Time frame: Baseline cross sectional data
Change in Fracture risk
Time frame: 10 year follow-up
Obstructive pulmonary disease
Time frame: Baseline cross sectional data
Obstructive pulmonary disease
Time frame: 10 year follow-up
Prevalence of Peripheral artery disease
Time frame: Baseline cross sectional data
Change in Peripheral artery disease
Time frame: 10 years follow-up
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 21 Jan 2026.
- Derived from this study: PubMed 42119773Suarez-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.
- Derived from this study: PubMed 41778959Knudsen 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.
- Derived from this study: PubMed 38570629Suarez-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.
- Derived from this study: PubMed 33794793Thomsen 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.
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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. This study is not recruiting at the moment.
Susanne D Rasmussen, Professor, MD, DMSc principal investigator
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Allan Rasmussen, MD study director
Department of Transplantation and Digestive Diseases, Copenhagen University Hospital - Rigshospitalet
Klaus F Kofoed, Professor, MD, PhD, DMSc study director
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Comorbidities and Coexisting Conditions, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of coronary artery disease (time frame: Baseline cross-sectional data). The study lists 18 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 NCT04777032, which also lists 4 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 21 Jan 2026.