EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 231
- 主要终点
- The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit
研究概览
简要总结
The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.
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
- •Female and male patients ≥ 18 years of age, diagnosed with CTEPH regardless of the current treatment
- •Availability of a signed informed consent
- •WHO Pulmonary Hypertension clinical classification Group IV (CTEPH):
- •Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:
- •Mean pulmonary arterial pressure (PAP) ≥ 25 mmHg at rest
- •Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg
- •Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:
- •At least 1 (segmental) perfusion defect(s) in ventilation/perfusion (V/Q) scan or
- •Pulmonary artery obstruction seen by MDCT (multidetector computed tomography) angiography or
- •Pulmonary artery obstruction seen by conventional pulmonary cineangiography (In case of suspicion/diagnosis of 'sub-acute' Pulmonary Embolism: Patients who are treated with anti-coagulation for at least 3 months before diagnosis of CTEPH)
排除标准
- •Patients with an underlying medical disorder with an anticipated life expectancy less than 6 months
- •Any medical condition which, in the opinion of the investigator, could jeopardize the safety of the patient or his/her compliance in the study, or otherwise make the patient inappropriate for study participation
结局指标
主要结局
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit
时间窗: Up to 3 years
mPAP (mean Pulmonary Arterial Pressure)
The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit
时间窗: Up to 3 years
6MWD (6 Minutes Walking Distance)
The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of WHO Functional Class between initial and final visit
时间窗: Up to 3 years
WHO Functional class (World Health Organization Functional Class)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit
时间窗: Up to 3 years
CI (Cardiac Index)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit
时间窗: Up to 3 years
PVR (Pulmonary Vascular Resistance)
次要结局
- Time span between onset of symptoms and CTEPH diagnosis(Up to 3 years)
- NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels(Up to 3 years)
- Number of healthcare professional visits due to CTEPH and CTEPH related complications(Up to 3 years)
- The total number of days of hospitalization due to CTEPH and CTEPH related complications(Up to 3 years)
- Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy(Up to 3 years)
- Usage of diagnostic tools of CTEPH patients (Y/N)(Up to 3 years)
- Changes in CTEPH treatment during the study period(Up to 3 years)
- Number of patients eligible for Balloon Pulmonary Angioplasty(Up to 3 years)
- Number of patients eligible for Pulmonary endarterectomy(Up to 3 years)
- Eligibility for PEA(Up to 3 years)
- Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit(Up to 3 years)
- Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit(Up to 3 years)
- Mortality due to CTEPH and CTEPH related complications(Up to 3 years)