RecruitingNCT05311072

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

A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)


Sponsor

China-Japan Friendship Hospital

Enrollment

1,500 participants

Start Date

Oct 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 Years

Inclusion Criteria4

  • 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 Criteria3

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

Interventions

PROCEDUREpulmonary endarterectomy or balloon pulmonary angioplasty

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


Locations(1)

China-Japan Frendship hospital

Beijing, China

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NCT05311072


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