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临床试验/NCT04543825
NCT04543825已完成不适用

Usefulness of Cardiopulmonary Exercise Testing for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates

Andres Duarte-Rojo2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Cardiopulmonary exercise testing and cardiac stress testing

研究概览

简要总结

Patients undergoing liver transplantation (LT) have a high risk for cardiovascular disease (CVD). Frailty is a frequent condition among LT candidates. Together, CVD and frailty are major causes of morbidity and mortality before and after LT. Conventional methods to diagnose and predict CVD in LT candidates lack sensitivity and clinically relevant application. However, cardiopulmonary exercise testing (CPET) can directly estimate coronary artery disease, cirrhotic cardiomyopathy, and indirectly assess frailty. Such versatility of CPET has caused it to become the standard of care in many LT centers outside of the United States.

In preliminary work (funded internally by the Pittsburgh Liver Research Center) that will be used to fund a more definitive study (RO1), the investigators plan to investigate CVD and frailty in LT candidates, both from existing standard of care (SOC) methods and CPET. The investigators expect results to improve the current capacity to assess and prognosticate CVD and frailty in LT, ultimately changing practice.

详细描述

Patients undergoing liver transplantation (LT) have a high risk for cardiovascular disease (CVD). Frailty is a frequent condition among LT candidates. Together, CVD and frailty are major causes of morbidity and mortality before and after LT. Conventional methods to diagnose and predict CVD in LT candidates lack sensitivity and clinically relevant application. However, cardiopulmonary exercise testing (CPET) can directly estimate coronary artery disease, cirrhotic cardiomyopathy, and indirectly assess frailty. Such versatility of CPET has caused it to become the standard of care in many LT centers outside of the United States. In preliminary work that will be used to fund a more definitive study (RO1), the investigators plan to investigate CVD and frailty in LT candidates, both from existing standard of care (SOC) methods and CPET. The investigators expect results to improve the assessment of CVD and frailty in LT, ultimately changing practice. The investigators' proposal will pursue the following Specific Aims (SA):

Aim 1: Prospectively determine agreement between cardiopulmonary exercise testing and cardiac stress testing, for the identification of subclinical coronary artery disease in liver transplant candidates.

Aim 2: Prospectively determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (DSE) or impedance cardiography, for the identification of cirrhotic cardiomyopathy in liver transplant candidates.

Aim 3: Prospectively determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test, for the identification of frailty in liver transplant candidates.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Wait listed patients with cirrhosis or those undergoing LT evaluation

排除标准

  • Subjects younger than 45 or older than 75 years
  • Subjects with platelets <30,000
  • Subjects with international normalized range (INR) >3
  • Subjects with glomerular filtration rate (GFR) <30
  • Subjects with left main artery stenosis
  • Subjects with moderate/severe stenotic valvular disease
  • Subjects with atrial fibrillation and other arrythmias
  • Subjects with resting ventricular ejection fraction <50%
  • Subjects with portopulmonary hypertension
  • Subjects with severe chronic obstructive pulmonary disease (COPD)
  • Subjects with an exercise contraindication

结局指标

主要结局

Cardiopulmonary exercise testing and cardiac stress testing

时间窗: 12 months

Agreement between cardiopulmonary exercise testing and cardiac stress testing, for the identification of subclinical coronary artery disease in liver transplant candidates.

Cardiopulmonary exercise testing and dobutamine stress echocardiogram

时间窗: 12 months

Agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (DSE) or impedance cardiography, for the identification of cirrhotic cardiomyopathy in liver transplant candidates.

Peak oxygen consumption from cardiopulmonary exercise testing

时间窗: 12 months

Agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test, for the identification of frailty in liver transplant candidates.

次要结局

未报告次要终点

研究者

发起方
Andres Duarte-Rojo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andres Duarte-Rojo

Associate Professor

University of Pittsburgh

研究点 (2)

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