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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 14 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) 2. Patients must be willing to provide informed consent. 3. 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:

1. Main cause of PH other than CTEPH. 2. Participation in a therapeutic clinical trial with an unknown drug; 3. Withdrawal or lack of informed consent.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


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Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

China-Japan Friendship Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Thromboembolic Pulmonary Hypertension
Additional Details

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.

Arms & Interventions


: 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


Procedure: - pulmonary endarterectomy or balloon pulmonary angioplasty

A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

China-Japan Frendship hospital, Beijing, China




China-Japan Frendship hospital

Beijing, , 100029

Site Contact

Zhenguo Zhai, Ph D

+86 10 84206269

For more information, please contact PHA at and refer to the terms of service below.

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