Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.
详细描述
Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age > 18 with echocardiographic confirmation of increased pulmonary pressure (eg. estimated RVSP >40mmHg, evidence of RV dilatation etc), and no apparent reversible causes.
- •Patients with reasonable pre-morbids and is able to attend ambulatory clinic.
排除标准
- •Inability to provide valid consent by the patient or his legal guardian
结局指标
主要结局
All-cause mortality
时间窗: 3-monthly
All-cause mortality
WHO functional class
时间窗: 3-monthly
Change in functional class (class I as the mildest to class IV as more severe) as measured by WHO functional class over times
EMPASIS-10 questionnaires
时间窗: 3-monthly
Change in disease-specific health-related quality of life (QoL) as measured by EMPASIS-10 questionnaires which is an independent prognostic marker in patients with (I/D/H)PAH or CTD-PAH
pulmonary hypertension related mortality
时间窗: 3-monthly
pulmonary hypertension related mortality
Borg Rating of perceived exertion (RPE) scale
时间窗: 3-monthly
Change in disease-specific health-related quality of life (QoL) as measured by Borg RPE scale which is an outcome measure scale used to gauge one's exercise intensity without the need to rely on physiological parameters
The 5-level EQ-5D version (EQ-5D-5L)
时间窗: 3-monthly
Change in disease-specific health-related quality of life (QoL) as measured by EQ-5D-5L which is for assessing patient health states for clinical and economic appraisal
The Modified Medical Research Council (mMRC) Dyspnea scale
时间窗: 3-monthly
Change in disease-specific health-related quality of life (QoL) as measured by mMRC which use to access stratifies severity of dyspnea in respiratory diseases, particularly COPD
Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL)
时间窗: 3-monthly
Change in disease-specific health-related quality of life (QoL) as measured by PEmb-QoL which use to access QoL following PE
次要结局
- physical parameters(3-monthly)
- daily activity level(3-monthly)
- Natriuretic Peptide Tests (NT-proBNP) level(3-monthly)
- Six-minute walking test (6MWT)(3-monthly)
- Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters(3-monthly)
- hemodynamic parameters(3-monthly)
- PH specific medications number and dosage(3-monthly)
- costs of all services, medications and tests(3-monthly)
- clinical parameters(3-monthly)
- laboratory parameters(3-monthly)
研究者
GuangMing Tan
assistant professor
Chinese University of Hong Kong