Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pulmonary endarterectomy or balloon pulmonary angioplasty.
- Who it may be relevant to
- Registry conditions: Chronic Thromboembolic Pulmonary Hypertension. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)
Overview
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.
Detailed description
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.
Interventions
- Procedure pulmonary endarterectomy or balloon pulmonary angioplasty
A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.
Primary outcome measures
- 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). [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. [Time frame: 3 years]
Secondary outcome measures (2)
- lung or heart and lung transplantation [Time frame: 3 years]
- changes of health related quality of life [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
- Patients must be willing to provide informed consent
- Patients must meet the following criteria for CTEPH:
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
- Main cause of PH other than CTEPH
- Participation in a therapeutic clinical trial with an unknown drug;
- Withdrawal or lack of informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Frendship hospital — Beijing
Publications
- 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 Me PMID 38825688
Identifiers
NCT: NCT05311072 · Change-CTEPH