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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04777032
Other study ID # Sponsor1 - Rigshospitalet
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date January 1, 2043

Study information

Verified date April 2024
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date January 1, 2043
Est. primary completion date September 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: - Liver transplanted - age between 16 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


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Aarhus Universitetshospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Odense Universitetshospital Odense

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of coronary artery disease Assessed by coronary CT angiography Baseline cross-sectional data
Primary Change in Coronary artery disease Assessed by coronary CT angiography 10 years follow-up
Primary Cardiac function Determined by transthoracic echocardiography Baseline cross-sectional data
Primary Change in Cardiac function Determined by transthoracic echocardiography 10 years follow-up
Primary Cardiac structure Determined by transthoracic echocardiography Baseline cross-sectional data
Primary Change in cardiac structure Determined by transthoracic echocardiography 10 years follow-up
Primary Cardiac structure Assessed by cardiac computed tomography (CT) Baseline cross-sectional data
Primary Change in Cardiac structure Assessed by cardiac computed tomography (CT) 10 years follow-up
Primary Cardiac function Assessed by cardiac computed tomography (CT) Baseline cross-sectional data
Primary Change in Cardiac function Assessed by cardiac computed tomography (CT) 10 years follow-up
Primary Dynamic lung function indices assessed by spirometry FVC and FEV1 assessed by spirometry Baseline cross-sectional data
Primary Change in Dynamic lung function indices assessed by spirometry FVC and FEV1 assessed by spirometry 10 years follow-up
Primary Renal function Estimated glomerular filtration rate Baseline cross-sectional data
Primary Change in Renal function Estimated glomerular filtration rate 10 years follow-up
Primary Metabolic diseases Prevalence of Diabetes Baseline cross-sectional data
Primary Metabolic diseases Change in Diabetes 10 years follow-up
Primary Metabolic diseases Prevalence of Dyslipidaemia Baseline cross-sectional data
Primary Metabolic diseases Change in Dyslipidaemia 10 years follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Obstructive pulmonary disease Nitric oxide in exhaled breath Baseline cross sectional data
Secondary Obstructive pulmonary disease Change in Nitric oxide in exhaled breath 10 year follow-up
Secondary 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
Secondary 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
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