Clinical trial NCT04777032: The Danish Comorbidity in Liver Transplant Recipients Study
Official title: The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Transplantation
Comorbidities and Coexisting Conditions
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All liver transplanted individuals in Danmark.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of coronary artery disease
timeFrame: Baseline cross-sectional data
measure: Change in Coronary artery disease
timeFrame: 10 years follow-up
measure: Cardiac function
timeFrame: Baseline cross-sectional data
measure: Change in Cardiac function
timeFrame: 10 years follow-up
measure: Cardiac structure
timeFrame: Baseline cross-sectional data
measure: Change in cardiac structure
timeFrame: 10 years follow-up
measure: Cardiac structure
timeFrame: Baseline cross-sectional data
measure: Change in Cardiac structure
timeFrame: 10 years follow-up
measure: Cardiac function
timeFrame: Baseline cross-sectional data
measure: Change in Cardiac function
timeFrame: 10 years follow-up
measure: Dynamic lung function indices assessed by spirometry
timeFrame: Baseline cross-sectional data
measure: Change in Dynamic lung function indices assessed by spirometry
timeFrame: 10 years follow-up
measure: Renal function
timeFrame: Baseline cross-sectional data
measure: Change in Renal function
timeFrame: 10 years follow-up
measure: Metabolic diseases
timeFrame: Baseline cross-sectional data
measure: Metabolic diseases
timeFrame: 10 years follow-up
measure: Metabolic diseases
timeFrame: Baseline cross-sectional data
measure: Metabolic diseases
timeFrame: 10 years follow-up
Secondary outcomes:
measure: Prevalence of Depression
timeFrame: Baseline cross sectional data
measure: Change in Depression
timeFrame: 10 years follow-up
measure: Fracture risk
timeFrame: Baseline cross sectional data
measure: Change in Fracture risk
timeFrame: 10 year follow-up
measure: Obstructive pulmonary disease
timeFrame: Baseline cross sectional data
measure: Obstructive pulmonary disease
timeFrame: 10 year follow-up
measure: Prevalence of Peripheral artery disease
timeFrame: Baseline cross sectional data
measure: Change in Peripheral artery disease
timeFrame: 10 years follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
name: Susanne D Rasmussen, Professor, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Transplantation and Digestive Diseases, Copenhagen University Hospital - Rigshospitalet
name: Allan Rasmussen, MD
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, Copenhagen University Hospital - Rigshospitalet
name: Klaus F Kofoed, Professor, MD, PhD, DMSc
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Tor Biering-Sørensen, Professor, MD, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: Thomsen 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.