3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension (HTP3S)
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Nice、法国、06000
- 招聘中
- Hôpital Pasteur - CHU Nice
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接触：
- PAMELA MOCERI, MD
- 电话号码：+33 4 92 03 77 34
- 邮箱：moceri.p@chu-nice.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients > 18 years old
- Pulmonary hypertension diagnosed by right heart catheterization
- Informed consent obtained
- Affiliation to the French national health insurance
Exclusion Criteria:
- Associated significant left heart disease
- Sub-optimal acoustic windows
- Patient unable to attend follow-up visits
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Case
Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months
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Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.
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Control
Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline
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Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of death from any cause
大体时间：Baseline to 24 months
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Description of the number of death during the study
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Baseline to 24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Hospitalisation
大体时间：Baseline to 24 months
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Description of the number of hospitalisation for worsening of pulmonary arterial hypertension
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Baseline to 24 months
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3D right ventricular imaging echocardiographic
大体时间：Baseline and 6 months
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Analyse the data of 3D right ventricular (RV), ejection fraction, RV telediastolic and telesystolic volume, 3D RV area strain (%)
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Baseline and 6 months
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合作者和调查者
调查人员
- 首席研究员：PAMELA MOCERI, MD、CHU Nice
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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