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

Recruiting
14 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details

Chronic Thromboembolic Pulmonary Hypertension

NCT05311072

China-Japan Friendship Hospital

29 January 2024

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