跳至主要内容
临床试验/NCT04947384
NCT04947384撤回不适用

Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月21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
入组人数
120
试验地点
1
主要终点
Biomarker analysis

研究概览

简要总结

The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.

详细描述

The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.

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

入选标准

  • >= 18 years/old

排除标准

  • Patients with ejection fraction (EF) < 35%
  • Patients with severe tricuspid valve regurgitation
  • Transplant patients
  • Patients scheduled for ventricular assist devices
  • Patients with a diagnosis of heart failure with preserved ejection fraction
  • Any aortic valvular disease

研究组 & 干预措施

Patients with moderate mitral valve disease, undergoing interventions

Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures.

干预措施: To discern micro-RNA specific for right and left heart induced PH (Diagnostic Test)

Patients undergoing mitral valve interventions without pulmonary hypertension

Patients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control.

干预措施: To discern micro-RNA specific for right and left heart induced PH (Diagnostic Test)

Patients with precapillary pulmonary hypertension scheduled for right heart catheterization

Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control.

干预措施: To discern micro-RNA specific for right and left heart induced PH (Diagnostic Test)

结局指标

主要结局

Biomarker analysis

时间窗: From baseline through one year

observation of tissue anomalies in target patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Zaky

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

Loading locations...

相似试验