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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

Study type: Observational

Funder types: Other

Identifiers

NCT05311072

Change-CTEPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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 design

1,500 participants in 3 patient groups

PEA cohort

Description:

patients with CTEPH receiving PEA

Treatment:

Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

BPA cohort

Description:

patients with CTEPH receiving BPA

Treatment:

Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

Pulmonary arterial hypertension (PAH)-specific medication

Description:

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

Treatment:

Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty