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临床试验/NCT03166488
NCT03166488撤回不适用

Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography

Mayo Clinic0 个研究点开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
Change in liver stiffness between preoperative and postoperative MR elastography (MRE)

研究概览

简要总结

The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(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

研究组 & 干预措施

Tricuspid Valvular Repair Patients

Experimental

Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE) within 1 month preoperatively and as close to 6 months postoperatively as reasonably achievable.

干预措施: MRI (Device)

结局指标

主要结局

Change in liver stiffness between preoperative and postoperative MR elastography (MRE)

时间窗: baseline, approximately 6 months postoperatively

Increased liver stiffness often means there is chronic liver disease and fibrosis.

Change in tricuspid valve regurgitation measured by echocardiography

时间窗: baseline, approximately 6 months postoperatively

Increased liver stiffness may be due to a poorly functioning tricuspid valve.

次要结局

  • Change in Subject Functional Capacity(baseline, approximately 6 months postoperatively)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael L Wells

Principal Investigator

Mayo Clinic

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