Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
HYPID-2 study is an extension of HYPID study (NCT01443598) :
HYPID-2 is also an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization.
It concerns only incident patients (i.e patients included within 6 months after PH diagnosis) whereas HYPID concerned prevalent and incident cases.
The primary aim is the same than HYPID : identify prognostic factors
详细描述
Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.
In this context, PH represents an important factor of morbidity and mortality for these patients.
As in HYPID, the main purpose of HYPID-2 is to determine predictive factors of mortality within this cohort of incident patients (i.e patients included within 6 months after PH diagnosis).
In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of incident patients.
Each incident patient will be followed during 2 years at least.
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
- 否
入选标准
- •Patients newly diagnosed with:
- •Pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP > or = 25 mmHg, PCWP < or = 15 mmHg
- •Interstitial lung disease with diffuse infiltrative opacities on chest CT scan
排除标准
- •Pulmonary hypertension related to a thromboembolic disease
- •Respiratory disease other than diffuse interstitial lung disease
- •Any etiological factor of pulmonary arterial hypertension based on NICE 2013 classification other than diffuse interstitial lung disease
- •Any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency
结局指标
主要结局
Overall survival
时间窗: 2 years
Determine predictive factors of mortality
次要结局
- Progression-free survival(2 years)
- Response to therapy(2 years)
研究者
Vincent COTTIN
Professor Vincent COTTIN
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires