Zürich Pulmonary Hypertension Outcome Assessment Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
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.
详细描述
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Survival
时间窗: 10 years
Transplant free survival will be registered
Change in the 6 minute walk distance
时间窗: 10 years
The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
次要结局
- Hospital days(10 years)
- Hemodynamic parameters by echocardiography(10 years)
- Overnight sleep study parameters(10 years)
- Score in cognitive function tests(10 years)
- Score in health related Quality of Life (HRQoL) questionnaires(10 years)
- New York Heart association (NYHA) functional class(10 years)
- Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test(10 years)
- Cardiopulmonary exercise test parameters(10 years)
- ECG parameters(10 years)
- Motion, step counts, metabolic equivalent(10 years)
- red- and white blood cell counts(10 years)
- Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes(10 years)
- Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue(10 years)
- Time, maximal power in stair-ascent test(10 years)
- Performance in Sit to stand test(10 years)
- Level of C-reactive protein (CRP)(10 years)
- Level of N-terminal brain natriuretic peptide (BNP)(10 years)