Evaluation of Lung Doppler Signals in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Find specific features that characterize lung signals of PHTN patients in comparison to control patients
研究概览
简要总结
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.
详细描述
PROTOCOL SUMMARY
Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device: SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether these signals can be used in pulmonary hypertension diagnosis and monitoring.
Study Design:
Two study arms:
- Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
- Retrospective arm to measure LDS in patients in whom previous RHC confirmed the presence of PHTN.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Prospective arm:
- •Man or woman aged over
- •With suspicion or diagnosis of pulmonary hypertension.
- •Scheduled to undergo right heart catheterization
- •Able and willing to give informed consent.
- •Retrospective arm:
- •Man or woman aged over
- •With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.
- •Able and willing to give informed consent.
排除标准
- •Minor (aged < 18).
- •People unable or unwilling to give informed consent.
- •Hemodynamically unstable patients.
- •Pregnant women.
- •Prospective arm only:
- •Patients with contra-indication to right heart catheterization.
- •Patients incapable of performing a Valsalva maneuver.
- •Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma
结局指标
主要结局
Find specific features that characterize lung signals of PHTN patients in comparison to control patients
时间窗: 18 months
The outcomes will be elaborate by statistical analysis of whole group data
次要结局
未报告次要终点