The Danish Comorbidity in Liver Transplant Recipients Study

• Conditions: Liver Transplantation; Comorbidities and Coexisting Conditions

• Registration Number: NCT04777032
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Study Start: 2021-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2033-01-01
• Study Completion: 2043-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac structure	Baseline cross-sectional data	Assessed by cardiac computed tomography (CT)
Cardiac function	Baseline cross-sectional data	Assessed by cardiac computed tomography (CT)
Dynamic lung function indices assessed by spirometry	Baseline cross-sectional data	FVC and FEV1 assessed by spirometry
Metabolic diseases	10 years follow-up	Change in Dyslipidaemia
Prevalence of coronary artery disease	Baseline cross-sectional data	Assessed by coronary CT angiography
Change in Cardiac function	10 years follow-up	Assessed by cardiac computed tomography (CT)
Change in Cardiac structure	10 years follow-up	Assessed by cardiac computed tomography (CT)
Change in Dynamic lung function indices assessed by spirometry	10 years follow-up	FVC and FEV1 assessed by spirometry
Change in cardiac structure	10 years follow-up	Determined by transthoracic echocardiography
Change in Renal function	10 years follow-up	Estimated glomerular filtration rate
Change in Coronary artery disease	10 years follow-up	Assessed by coronary CT angiography
Renal function	Baseline cross-sectional data	Estimated glomerular filtration rate

Secondary Outcome Measures

Name	Time	Method
Prevalence of Depression	Baseline cross sectional data	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
Change in Depression	10 years follow-up	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
Fracture risk	Baseline cross sectional data	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).
Change in Fracture risk	10 year follow-up	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).
Obstructive pulmonary disease	10 year follow-up	Change in Nitric oxide in exhaled breath
Prevalence of Peripheral artery disease	Baseline cross sectional data	Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.
Change in Peripheral artery disease	10 years follow-up	Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.

Trial Locations

Locations (4)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Copenhagen University Hospital - Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark