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

NCT ID: NCT05311072

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Thromboembolic Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEA cohort

patients with CTEPH receiving PEA

pulmonary endarterectomy or balloon pulmonary angioplasty

Intervention Type PROCEDURE

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

BPA cohort

patients with CTEPH receiving BPA

pulmonary endarterectomy or balloon pulmonary angioplasty

Intervention Type PROCEDURE

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

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

pulmonary endarterectomy or balloon pulmonary angioplasty

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pulmonary endarterectomy or balloon pulmonary angioplasty

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PEA or BPA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhenguo Zhai,MD,PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China-Japan Frendship hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhenguo Zhai, Ph.D.

Role: CONTACT

+86 10 84206269

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhenguo Zhai, Ph D

Role: primary

+86 10 84206269

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38825688 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Change-CTEPH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

U.S. CTEPH Registry
NCT02429284 COMPLETED
Prognostic Model of Hypertension
NCT06160921 RECRUITING
China Rural Hypertension Control Project
NCT03527719 ACTIVE_NOT_RECRUITING NA