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临床试验/NCT02799979
NCT02799979已完成不适用

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Number of death from any cause

研究概览

简要总结

Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.

The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension.

To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.

研究设计

研究类型
Observational
观察模型
Case Control
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
是

入选标准

  • •Patients > 18 years old
  • •Pulmonary hypertension diagnosed by right heart catheterization
  • •Informed consent obtained
  • •Affiliation to the French national health insurance

排除标准

  • •Associated significant left heart disease
  • •Sub-optimal acoustic windows
  • •Patient unable to attend follow-up visits

研究组 & 干预措施

Control

Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline

干预措施: 3D right ventricular imaging echocardiographic (Device)

Case

Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months

干预措施: 3D right ventricular imaging echocardiographic (Device)

结局指标

主要结局

Number of death from any cause

时间窗: Baseline to 24 months

Description of the number of death during the study

次要结局

  • Number of Hospitalisation(Baseline to 24 months)
  • 3D right ventricular imaging echocardiographic(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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