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临床试验/NCT02087371
NCT02087371已完成不适用

Prognosis Factors of Cardiac Complications After Liver Transplantation

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 565 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
565
试验地点
1
主要终点
Cardiovascular complications

研究概览

简要总结

This is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

详细描述

Liver transplantation (LT) is the standard treatment for chronic or acute hepatic insufficiency with 87% of one-year survival. Cardiovascular complications are common after LT with an incidence at 6 months ranging between 25 and 50 %. These complications are associated with significant morbidity and represents the third cause of post LT mortality. Myocardial perfusion imaging or stress echocardiography, used for preoperative cardiovascular evaluation, are not enough efficient to predict the risk of post LT cardiovascular complications. However, to improve the prediction capacity of cardiovascular disease is fundamental in order to better select the candidates for LT or to develop preventive strategies. Such a strategy could reduce the morbidity and mortality from cardiovascular diseases after LT and improve the results of LT. Cardiovascular biomarkers such as troponin or natriuretic peptide are known to be predictive factors of postoperative cardiovascular complications in non cardiac surgery. The use of biomarkers in combination with conventional tests could improve the preoperative prediction of post LT cardiovascular complications.

Hypothesis

The preoperative biomarkers dosage could improve the prediction of cardiovascular complications occurring in the year after LT.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cardiovascular complications

时间窗: 1 year after liver transplantation

Identify risk factors for occurrence of cardiovascular complications in the year following the transplantation. Cardiovascular complications include myocardial infarction, increase of cardiac troponin, cardiogenic pulmonary edema, cardiogenic shock, ventricular or supraventricular arrhythmia requiring treatment, de novo arterial hypertension and death of cardiac cause.

次要结局

  • Gather a biological plasma and urine samples collection for study of new biomarkers.(7 days after liver transplantation)
  • Describe prospectively cardiovascular complications after liver transplantation(1 year after liver transplantation)
  • Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year.(1 year after liver transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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