The Danish Comorbidity in Liver Transplant Recipients Study

Liver Transplantation Clinical Trial

— DACOLT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04777032
• Other study ID #: Sponsor1 - Rigshospitalet
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• Liver Transplantation

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