跳至主要内容
临床试验/NCT06663566
NCT06663566Enrolling By Invitation不适用

Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
1
主要终点
Right heart dysfunction

研究概览

简要总结

"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.

In recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging's efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.

The comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration."

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;

排除标准

  • •Combined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;

结局指标

主要结局

Right heart dysfunction

时间窗: 3 mouths

TAPSE

次要结局

未报告次要终点

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaozheng Zhou

Doctor, Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, Beijing 100029, China

Beijing Anzhen Hospital

研究点 (1)

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