Database for Clinical and Anamnestic Data in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Collecting data in a PH patient database
研究概览
简要总结
Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg measured in the right heart catheterization.
There are different forms of PH defined in the classification of Dana Point 2008.
PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like the echocardiography, stress echocardiography and cardio pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which can make the diagnosis process easier and predict prognosis.
The systematic data collection in a data base provides better information about patients in daily routine and clinical studies as well as in the design of new studies.
详细描述
In this study the investigators want to collect clinical data of PH patients and controls in a database as well as blood samples in a biobank. The combination of anamnestic and clinical data and biomarkers should provide a better characterization of our patients and should improve the analysis of the disease development of different PH forms and therapeutic aspects.
After given informed consent patients' data are entered in a database at different time points. The database includes parameter of several invasive and non-invasive investigations like right heart catheterization (RHC), echocardiography, ECG, pulmonary function tests, cardiorespiratory exercise testing, 6-minute walk test, computed tomography, MRI, polysomnography, blood gas analysis and laboratory data as well as demographic data of the patients.
The blood samples are taken during routine punctuation and are stored in our biobank.
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 with pulmonary hypertension
- •patients at risk for getting pulmonary hypertension
- •patients who have symptoms which my be due to pulmonary hypertension when we have their written informed consent.
排除标准
- •patients without written informed consent
研究组 & 干预措施
Patients of our outpatient clinic
Patients who have an investigation in our outpatient clinic for pulmonary hypertension like a echocardiography, a right heart catheterization or a cardio pulmonary exercise testing
结局指标
主要结局
Collecting data in a PH patient database
时间窗: After one year: first analysis of retrospectively collected data. Ongoing data collection: new data of patients who are already in the database, new patients (3-4 years)
Retrospective and prospective data input and constant update
次要结局
未报告次要终点