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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans (PITCH)

2026年7月17日更新者：Manhal Izzy、Vanderbilt University Medical Center

Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, this study will be the first contemporary prospective multicenter investigation of CCM in adults with cirrhosis in the United States. The study will characterize risk factors for CCM, determine its impact on clinical outcomes, and investigate the contribution of circulating bile acids to disease development.

研究概览

地位

招聘中

条件

肝硬化性心肌病

详细说明

Cirrhotic cardiomyopathy (CCM) is a recognized but understudied and not well understood complication of cirrhosis. CCM is defined as subclinical (i.e., silent) heart dysfunction identified by echocardiography in patients with cirrhosis in the absence of other heart diseases such as significant coronary artery, valvular, or pericardial disease. Initial small studies indicate that CCM is common and it warrants larger prospective study in humans to address unanswered questions highly relevant to clinical care. These include 1) what are the associations between CCM and cirrhosis-related outcomes, adverse cardiac events, and survival 2) what clinical factors increase the risk for CCM, and 3) do bile acids levels, which are produced by the liver, in the blood associate with features of CCM.

研究类型

观察性的

注册 (估计的)

440

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。

学习联系方式

姓名：Manhal Izzy, MD
电话号码：615-875-6540
邮箱：manhal.izzy@vumc.org

研究联系人备份

姓名：Deepak Gupta, MD
邮箱：d.gupta@vumc.org

学习地点

美国
- Tennessee
  - Nashville、Tennessee、美国、37203
    - 招聘中
    - Vanderbilt University Medical Center
    - 首席研究员：
      
      Manhal Izzy, MD
    - 接触：
      
      Manhal Izzy
      
      电话号码：MD
      
      邮箱：manhal.izzy@vumc.org
    - 副研究员：
      
      Deepak Gupta, MD
- Texas
  - Dallas、Texas、美国、75390
    - 招聘中
    - UT Southwestern Medical Center
    - 接触：
      
      Lisa VanWagner,, MD
      
      电话号码：214-648-3111
      
      邮箱：Lisa.Vanwagner@UTSouthwestern.edu
    - 副研究员：
      
      Lisa Vanwagner, MD

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

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Study population will be identified through clinic referrals and inpatient evaluations.

描述

Inclusion Criteria:

Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:
- portal hypertension-related bleeding,
- hepatic encephalopathy, and/or
- clinical ascites.
Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C
Age ≥ 18 years
Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics
Willing to adhere to study protocol
Able to provide written informed consent

Exclusion Criteria:

Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, > mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator
End-stage heart, kidney, or lung disease
Pulmonary Arterial Hypertension
Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)
Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)
Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing
Pregnancy
Prior TIPS

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

团体/队列数

队列和干预

团体/队列
Decompensated cirrhosis Patients with cirrhosis and current or prior occurrence of one or more of the following: • portal hypertension-related bleeding (a type of bleeding from the gut in patients with cirrhosis),• hepatic encephalopathy (i.e., alteration in mental status due to cirrhosis), and/or • clinical ascites (i.e., fluid build up in the abdomen). The cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy.

团体/队列

Decompensated cirrhosis

Patients with cirrhosis and current or prior occurrence of one or more of the following:

• portal hypertension-related bleeding (a type of bleeding from the gut in patients with cirrhosis),• hepatic encephalopathy (i.e., alteration in mental status due to cirrhosis), and/or • clinical ascites (i.e., fluid build up in the abdomen).

The cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy.

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
All-Cause Mortality 大体时间：Up to 4 years	Death from any cause occurring during the follow-up period. Mortality status will be ascertained through review of medical records.	Up to 4 years

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。

赞助

Vanderbilt University Medical Center

合作者

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

调查人员

首席研究员：Manhal Izzy, MD、Vanderbilt University Medical Center

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。

一般刊物

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 (实际的)

2026年1月20日

初级完成 (估计的)

2030年6月30日

研究完成 (估计的)

2030年6月30日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日