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

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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.

OriginalsprogEngelsk
Artikelnummer145
TidsskriftBMC Gastroenterology
Vol/bind21
Udgave nummer1
Sider (fra-til)145
ISSN1471-230X
DOI
StatusUdgivet - 1 apr. 2021

Bibliografisk note

Funding Information:
M.T.T. reports a grant from the Rigshospitalets Research Council. J.H. reports grant from Novo Nordisk Foundation and Rigshospitalets Research Council. A.D.K. reports a grant from the Danish Heart Foundation not in relation to this work. T.V. has served on scientific advisory panels, been part of speaker’s bureaus for, served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, MSD/Merck, Mundipharma, Novo Nordisk, Sanofi and Sun Pharmaceuticals. S.D.N. has received unrestricted research grants from Novo Nordisk Foundation, Svend Andersen Foundation, Kirsten and Freddy Johansen Foundation, Rigshospitalet Research Council. All other authors report no conflicts of interest.

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