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NCT05311072Recruiting

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)

Source: ClinicalTrials.gov · Last updated 23 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
17 Mar 2022
Start date
1 Oct 2015
Primary completion date
28 Feb 2025
Lead sponsor
China-Japan Friendship Hospital
NCT number
NCT05311072

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 1 Oct 2015 to the primary completion date, 28 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in a therapeutic clinical trial with an unknown drug;

Other

  • Main cause of PH other than CTEPH
  • Withdrawal or lack of informed consent.

Who the study is looking for

  • 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.

Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Frendship hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.