Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China

Study Overview
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Brief Summary
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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. The registry will run for approximately 5 years. It aims to illustrate the epidemiology, management and longterm outcomes of CTEPH.

Detailed Description
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15 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis， treatments (pulmonary endarterectomy (PEA) and balloon pulmonary angioplasty (BPA)), and long-term prognosis of CTEPH will be evaluated.

Official Title
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A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)

Conditions
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Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH Patients must be willing to provide informed consent Patients must meet the following criteria for CTEPH: Mean pulmonary artery pressure (PAP) ≥ 20 mmHg at rest Abnormal VQ scan, pulmonary angiogram, computed tomography (CT) pulmonary angiogram, or magnetic resonance (MR) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines Exclusion Criteria: Meet the criteria for inclusion into WHO Groups I, II, III, V Patients with an underlying medical disorder with an anticipated life expectancy less than 2 years

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEA cohort<br>patients with CTEPH receiving PEA | Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty<br>* A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.<br>* Other names: PEA or BPA;|
| BPA cohort<br>patients with CTEPH receiving BPA | Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty<br>* A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.<br>* Other names: PEA or BPA;|
| Non-interventional cohort<br>CTEPH patients without PEA or BPA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | all-cause death | 3 years | 
| change of heart function | using world Heath organization of function classification （WHO-FC）to assess heart function | 3 years | 
| 6MWD | 6-minute working distance | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with lung transplantation | lung transplantation due to severe right heart failure | 3 years | 
| number of participants with a significantly change of expiratory volume in one second | change of the expiratory volume in one second（FEV1） | 3 years | 
| number of participants with a significantly improved cardiac out | change of cardiac out （CO）using right heart catheterization | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Thromboembolic Pulmonary Hypertension, epidemiology, diagnosis, treatment, prognosis, balloon pulmonary angioplasty, pulmonary endarterectomy