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

Last updated: January 20, 2024
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

pulmonary endarterectomy or balloon pulmonary angioplasty

Clinical Study ID

NCT05311072
Change-CTEPH
  • Ages > 14
  • All Genders

Study 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 Criteria

Inclusion

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 vascularresistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented atright heart catheterization with radiographic evidence of organized thrombi involving thepulmonary arteries after 3 months of effective anticoagulation.

Exclusion

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.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: pulmonary endarterectomy or balloon pulmonary angioplasty
Phase:
Study Start date:
October 01, 2015
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • China-Japan Frendship hospital

    Beijing, 100029
    China

    Active - Recruiting

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