The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT)

Rigshospitalet

Status: Active, not recruiting

Conditions: Liver Transplantation; Comorbidities and Coexisting Conditions

Study type: Observational

Funder types: Other

Identifiers

NCT04777032

Sponsor1 - Rigshospitalet

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

600 participants in 3 patient groups

Liver transplant recipients

Description:

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

Description:

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

Description:

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.