The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT)
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ClinicalTrials.gov Identifier: NCT04777032 |
Recruitment Status :
Enrolling by invitation
First Posted : March 2, 2021
Last Update Posted : April 10, 2024
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Tracking Information | |||||||||||||||||||
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First Submitted Date | February 16, 2021 | ||||||||||||||||||
First Posted Date | March 2, 2021 | ||||||||||||||||||
Last Update Posted Date | April 10, 2024 | ||||||||||||||||||
Actual Study Start Date | March 15, 2021 | ||||||||||||||||||
Actual Primary Completion Date | September 27, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title | 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 | ||||||||||||||||||
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. |
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Detailed Description | Not Provided | ||||||||||||||||||
Study Type | Observational | ||||||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||||||
Biospecimen | Retention: Samples Without DNA Description: Biochemical analyses including fasting insulin and fasting blood glucose. Blood will be collected for a research biobank, and peripheral blood mononuclear cells, serum and plasma will be stored for further analyses of inflammation markers (chemokines, cytokines, soluble surface markers), coagulation markers (standard and functional platelet aggregation test), simulation assays and flowcytometry of PBMC, endothelial function markers (asymmetric dimethylarginine (ADMA), syndecan-1, trombomodulin and sE-selectin), markers of microbial translocation and bacterial degradation (sCD14, lipopolysaccharide, trimethylamine N-oxide), markers of lung tissue (alpha-1-antitrypsine, endothelin-1), liver markers (hyaluronic acid and fibrosis markers) and metabolomics and multiomics.
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Sampling Method | Non-Probability Sample | ||||||||||||||||||
Study Population | All liver transplanted individuals in Danmark. | ||||||||||||||||||
Condition |
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Intervention | Not Provided | ||||||||||||||||||
Study Groups/Cohorts |
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Publications * | 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. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status | Enrolling by invitation | ||||||||||||||||||
Estimated Enrollment |
600 | ||||||||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||||||||
Estimated Study Completion Date | January 1, 2043 | ||||||||||||||||||
Actual Primary Completion Date | September 27, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 100 Years (Child, Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries | Denmark | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number | NCT04777032 | ||||||||||||||||||
Other Study ID Numbers | Sponsor1 - Rigshospitalet | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||||||||||||
Current Responsible Party | Susanne Dam Nielsen, MD, DMSc, Rigshospitalet, Denmark | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor | Rigshospitalet, Denmark | ||||||||||||||||||
Original Study Sponsor | Same as current | ||||||||||||||||||
Collaborators | Not Provided | ||||||||||||||||||
Investigators |
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PRS Account | Rigshospitalet, Denmark | ||||||||||||||||||
Verification Date | April 2024 |