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Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)

2022年11月1日 更新者:University of Zurich
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigators intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters.

研究概览

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

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Zurich、瑞士、8091
        • 招聘中
        • University Hospital Zurich
        • 接触:
        • 首席研究员:
          • Silvia Ulrich, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with precapillary pulmonary hypertension classified according to WHO

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
PH target therapy
Patients receiving PH target therapy
Patients receiving PH target therapy

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
Change in the 6 minute walk distance
大体时间:10 years
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
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
Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
大体时间:10 years
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)
10 years
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
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
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
10 years
Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
大体时间:10 years
Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
10 years
Time, maximal power in stair-ascent test
大体时间:10 years
Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
10 years
Performance in Sit to stand test
大体时间:10 years
Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
10 years
Level of C-reactive protein (CRP)
大体时间:10 years
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年9月1日

初级完成 (预期的)

2024年9月1日

研究完成 (预期的)

2024年9月1日

研究注册日期

首次提交

2014年9月16日

首先提交符合 QC 标准的

2014年9月25日

首次发布 (估计)

2014年9月26日

研究记录更新

最后更新发布 (实际的)

2022年11月2日

上次提交的符合 QC 标准的更新

2022年11月1日

最后验证

2022年11月1日

更多信息

与本研究相关的术语

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