Journal Article

The Danish comorbidity in liver transplant recipients study (DACOLT): a non-interventional prospective observational cohort study

Kofoed, Klaus Fuglsang, Nordestgaard, Børge Grønne, Rasmussen, Allan, Thomsen, Magda Teresa, Abazi, Rozeta, Biering-Sørensen, Tor, Høgh, Julie, Clemmesen, Otto, Hillingsø, Jens, Gelpi, Marco, Krohn, Paul Suno, Knudsen, Andreas Dehlbæk, Jensen, Anne Marie Reimer, Nielsen, Susanne Dam, Vilsbøll, Tina, Holland-Fischer, Peter, Villadsen, Gerda E., Køber, Lars

2021

Overview

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. However, long-term survival has not improved to the same extent as the short-term survival, and the 10-year survival after liver transplantation is 60%. 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 Danish Comorbidity in Liver Transplant Recipients (DACOLT) study is an observational, longitudinal study. We aim to include all adult liver transplant recipients in Denmark (n = approx. 600). 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, ankle–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 DACOLT, CGPS, and CCHS. 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. This study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on management, treatment and screening and thereby contribute to improvement of the long-term survival. Trial registration ClinicalTrials.gov: NCT04777032; date of registration: March 02, 2021.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Angiography / Ankle / Blood pressure / Cardiovascular diseases / Chemokines / Cohort analysis / Cohort Studies / Comorbidity / Computed tomography / Contraindications / Cytokines / Denmark - epidemiology / Diabetes / Echocardiography / EKG / Electrocardiography / Gastroenterology / Hepatobiliary and pancreatic disorders / Hepatology / Humans / Immunosuppressive agents / Internal Medicine / Liver / Liver diseases / Liver Transplantation / Liver transplants / Longitudinal Studies / Lung diseases / Medical imaging / Medicine / Medicine & Public Health / Metabolic diseases / Metabolic disorders / Metabolic syndrome / Morbidity / Mortality / Nitric oxide / Non-pharmacological intervention / Observational studies / Organ transplant recipients / Pathogenesis / Population / Population studies / Prospective Studies / Questionnaires / Renal diseases / Respiratory diseases / Risk Factors / Spirometry / Statistics / Study Protocol / Survival / Transplantation