Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
研究概览
简要总结
The main objective of this study is to analyze the survival of a cohort of patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension and to establish the prognostic value of biomarkers.
详细描述
It is planned to include 150 patients over a two-year period. The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit. Patients will be treated according to the usual practice. A biobank will be created from blood samples taken at admission, days 3 and days 7. Prognostic value of pre-selected biomarkers will be analyzed and a proteomic analysis will be performed in order to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual monitoring parameters that will be collected during follow-up (clinical, echocardiographic and haemodynamic parameters). In a second step, it will establish, using a dynamic model, the best combinations of parameters allowing to best assessment of prognosis of patients suffering from PH and hospitalized for acute right ventricular failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients over 18 years
- •Diagnosis of Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study
- •Patients admitted in intensive care unit for acute decompensation of pulmonary hypertension requiring intravenous diuretic therapy ± use of inotropes or vasopressors.
- •Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures
排除标准
- •Patients with post-capillary pulmonary hypertension
- •Patients with pulmonary hypertension associated with chronic respiratory disease
- •Patients with pulmonary hypertension with unclear/or multifactorial mechanisms
- •Patients with operable chronic thromboembolic pulmonary hypertension
- •Shock due to another cause than acute decompensation of pulmonary hypertension
- •Pregnant women, or breast feeding women
- •Adult protected person
- •Person deprived of liberty
- •Person admitted without consent
- •Pregnant or breastfeeding women
结局指标
主要结局
time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
时间窗: 90 days
The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
次要结局
- Survival time without transplantation or circulatory assitance(12 months)
- Survival time without graft or circulatory assistance(1 month)