The Change Database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (CTEPH) in China. It aims to illustrate the epidemiology, management and long-term outcomes of CTEPH.
18 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis,treatments (pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and targeted medical therapy), and long-term prognosis of CTEPH will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
1,500
A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.
China-Japan Frendship hospital
Beijing, China
RECRUITINGdeath
all-cause death
Time frame: 3 years
The change in mean pulmonary artery pressure (mPAP) in millimetre of mercury (mmHg), pulmonary vascular resistance (PVR) in Wood units, cardiac output (CO) in liter per minute (L/min) or cardiac index (CI) in liter per minute (L/min).
mPAP, PVR, CO, and CI constitute critical parameters in hemodynamic assessments.
Time frame: 3 years
The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter(pg/ml), or WHO-functional class.
The 6-minute walk distance, BNP or NT-proBNP levels, and WHO-functional class are parameters used in the evaluation of functional capacity.
Time frame: 3 years
lung or heart and lung transplantation
proportion of patients experiencing lung or heart and lung transplantation due to severe right heart failure during the study
Time frame: 3 years
changes of health related quality of life
change of quality of life measured with the EQ-5D-5L or EmPHasis-10
Time frame: 3 years
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