Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)
研究概览
地位
详细说明
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Silvia Ulrich, MD
- 电话号码:++41442552220
- 邮箱:pulmonalehypertonie@usz.ch
研究联系人备份
- 姓名:Isabel Schmied
- 电话号码:++41442552220
- 邮箱:pulmonalehypertonie@usz.ch
学习地点
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-
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Zurich、瑞士、8091
- 招聘中
- University Hospital Zurich
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接触:
- Silvia Ulrich, PD MD
- 电话号码:0041 44 255 22 20
- 邮箱:silvia.ulrich@usz.ch
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首席研究员:
- Silvia Ulrich, MD
-
-
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 with precapillary pulmonary hypertension
- Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
- Written informed consent by the subject after information about the research project
Exclusion Criteria:
- Patients with severe concomitant left heart disease (left ventricular ejection fraction <40%).
- Patients with restrictive lung disease (FVC<60% predicted); obstructive lung disease (forced expiratory volume (FEV) <60% predicted, with FEV 1/FVC<70%).
- Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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PH target therapy
Patients receiving PH target therapy
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Patients receiving PH target therapy
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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 |
|---|---|---|
|
Survival
大体时间:10 years
|
Transplant free survival will be registered
|
10 years
|
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Change in the 6 minute walk distance
大体时间:10 years
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The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
New York Heart association (NYHA) functional class
大体时间:10 years
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The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Score in health related Quality of Life (HRQoL) questionnaires
大体时间:10 years
|
The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hemodynamic parameters by echocardiography
大体时间:10 years
|
The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hospital days
大体时间:10 years
|
Days spent in the hospital
|
10 years
|
|
red- and white blood cell counts
大体时间:10 years
|
The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
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Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
大体时间:10 years
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The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)
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10 years
|
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Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
大体时间:10 years
|
The change in utility will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Overnight sleep study parameters
大体时间:10 years
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The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Score in cognitive function tests
大体时间:10 years
|
The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Cardiopulmonary exercise test parameters
大体时间:10 years
|
The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
ECG parameters
大体时间:10 years
|
The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
|
Motion, step counts, metabolic equivalent
大体时间:10 years
|
The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
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10 years
|
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Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
大体时间:10 years
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Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
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10 years
|
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Time, maximal power in stair-ascent test
大体时间:10 years
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Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
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10 years
|
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Performance in Sit to stand test
大体时间:10 years
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Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
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10 years
|
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Level of C-reactive protein (CRP)
大体时间:10 years
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The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)
|
10 years
|
|
Level of N-terminal brain natriuretic peptide (BNP)
大体时间:10 years
|
The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)
|
10 years
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合作者和调查者
调查人员
- 首席研究员:Silvia Ulrich, MD、University Hospital Zurich, Department of Pulmonology
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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