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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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA cohort | patients with CTEPH receiving PEA |
| |
| BPA cohort | patients with CTEPH receiving BPA |
| |
| Pulmonary arterial hypertension (PAH)-specific medication | CTEPH patients without PEA or BPA, treatment with any PAH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary endarterectomy or balloon pulmonary angioplasty | Procedure | A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| death | all-cause death | 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. | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| changes of health related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding | fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition | up to 3 years |
| symptomatic recurrence of DVT or PE | reappearance of clinical manifestations or symptoms associated with DVT or PE after a previous episode or treatment, include leg pain, swelling, warmth, redness, or shortness of breath,etc |
Inclusion Criteria:
a mean pulmonary artery pressures (mPAP) ≥20 mmHg combined with a pulmonary vascular resistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation.
Exclusion Criteria:
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Patients dianosed with CTEPH according to the contemporary guidelines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenguo Zhai, Ph.D. | Contact | +86 10 84206269 | zhaizhenguo2011@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Frendship hospital | Recruiting | Beijing | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38825688 | Derived | Zhang S, Li Y, Yang Y, Gong S, Yang Z, Hong C, Cui X, Wan J, Ji Y, Chen H, Zhu L, Li C, Cheng Z, Zhang Y, Wang Q, Luo Q, Guo L, Ma G, Han B, Liu Z, Xiong C, Wang L, Ji Q, Li F, Wang S, Zhang Z, Zhang Y, Wang D, Gao Q, Huang Q, Xie W, Zhai Z, Wang C. The management pattern and outcomes of chronic thromboembolic pulmonary hypertension: rationale and design for a Chinese real-world study. BMC Pulm Med. 2024 Jun 3;24(1):265. doi: 10.1186/s12890-024-03042-5. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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blood samples and PEA specimens of patients with CTEPH
|
change of quality of life measured with the EQ-5D-5L or EmPHasis-10
| 3 years |
| up to 3 years |
| complication of treatment interventions (PEA or BPA) | complications include lung injury, haemoptysis, residual pulmonary hypertension, etc. | up to 3 years |