The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Cardiac structure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Cardiac structure
时间窗: Baseline cross-sectional data
Assessed by cardiac computed tomography (CT)
Cardiac function
时间窗: Baseline cross-sectional data
Assessed by cardiac computed tomography (CT)
Dynamic lung function indices assessed by spirometry
时间窗: Baseline cross-sectional data
FVC and FEV1 assessed by spirometry
Metabolic diseases
时间窗: 10 years follow-up
Change in Dyslipidaemia
Prevalence of coronary artery disease
时间窗: Baseline cross-sectional data
Assessed by coronary CT angiography
Change in Cardiac function
时间窗: 10 years follow-up
Assessed by cardiac computed tomography (CT)
Change in Cardiac structure
时间窗: 10 years follow-up
Assessed by cardiac computed tomography (CT)
Change in Dynamic lung function indices assessed by spirometry
时间窗: 10 years follow-up
FVC and FEV1 assessed by spirometry
Change in cardiac structure
时间窗: 10 years follow-up
Determined by transthoracic echocardiography
Change in Renal function
时间窗: 10 years follow-up
Estimated glomerular filtration rate
Change in Coronary artery disease
时间窗: 10 years follow-up
Assessed by coronary CT angiography
Renal function
时间窗: Baseline cross-sectional data
Estimated glomerular filtration rate
次要结局
- Prevalence of Depression(Baseline cross sectional data)
- Change in Depression(10 years follow-up)
- Fracture risk(Baseline cross sectional data)
- Change in Fracture risk(10 year follow-up)
- Obstructive pulmonary disease(10 year follow-up)
- Prevalence of Peripheral artery disease(Baseline cross sectional data)
- Change in Peripheral artery disease(10 years follow-up)
研究者
Susanne Dam Nielsen, MD, DMSc
Professor, MD, DMSc
Rigshospitalet, Denmark