此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events

2011年9月13日 更新者:Angelo Antunes Salgado、Rio de Janeiro State University

Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events

The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.

These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.

To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • RJ
      • Rio de Janeiro、RJ、巴西、20551030
        • Universidade do Estado do Rio de Janeiro

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Will be selected patients with cirrhosis (diagnosed by clinical criteria and ultrasound and / or liver biopsy) at different evolutionary stages os disease in the hepatology's service at the University Hospital Pedro Ernesto.

描述

Inclusion Criteria:

  • Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
  • Age between 18 and 80 years.
  • Signing of written informed consent.

Exclusion Criteria:

  • History or presence of systemic arterial hypertension (treated or not)
  • History or presence of ischemic heart disease and peripheral vascular disease.
  • Presence of greater than mild valvular disease.
  • Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
  • Presence of severe anemia (Hb <7 g / dL).
  • Presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week.
  • History or presence of severe or decompensated lung disease.
  • Presence of percutaneous intrahepatic porto-systemic shunt (TIPS).
  • Pregnancy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Child A liver cirrhosis
Child B liver cirrhosis
Child C liver cirrhosis

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis.
大体时间:12 months follow-up

Identify the occurrence of adverse events as defined as:

  1. death due to liver failure, characterized by development of severe liver injury with impaired synthetic function and encephalopathy in a person who previously had well-compensated liver disease.
  2. either upper or lower gastrointestinal bleeding, characterized by hematemesis (vomiting of blood or coffee-ground like material) and/or melena (black, tarry stools).
  3. spontaneous bacterial peritonitis, characterized by as an ascitic fluid infection without an evident intraabdominal surgically-treatable source.
  4. liver transplant.
12 months follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Angelo A Salgado, Master、Rio de Janeiro State University
  • 学习椅:Carlos Terra, PHD、Rio de Janeiro State University
  • 学习椅:Márcia B Castier, PHD、Rio de Janeiro State University
  • 学习椅:Paulo R Benchimol-Barbosa, DSC、Rio de Janeiro State University
  • 首席研究员:Camila SS Reis, MD、Universidade de Estado do Rio de Janeiro

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年6月1日

研究注册日期

首次提交

2011年8月9日

首先提交符合 QC 标准的

2011年9月13日

首次发布 (估计)

2011年9月14日

研究记录更新

最后更新发布 (估计)

2011年9月14日

上次提交的符合 QC 标准的更新

2011年9月13日

最后验证

2011年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • arquivo1

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅