Prospective Investigation of Cirrhotic Cardiomyopathy in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- All-Cause Mortality
研究概览
简要总结
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.
详细描述
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
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
All-Cause Mortality
时间窗: Up to 4 years
Death from any cause occurring during the follow-up period. Mortality status will be ascertained through review of medical records.
次要结局
未报告次要终点
研究者
Manhal Izzy
Professor
Vanderbilt University Medical Center