Actively Recruiting

Age: 14Years +
All Genders
ID05311072

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

Led by China-Japan Friendship Hospital · Updated on 2024-01-23

1500

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a multi-center, observational study in China to collect detailed information about patients with chronic thromboembolic pulmonary hypertension (CTEPH). The study aims to better understand the occurrence, management, and long-term outcomes of this condition by gathering data from 18 specialized centers. It focuses on how CTEPH is diagnosed and treated in real-world settings, supported by the China-Japan Friendship Hospital. The study observes patients receiving different treatments for CTEPH, including pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), or various pulmonary arterial hypertension (PAH)-specific medications such as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Treatment decisions are made by a multidisciplinary team based on each patient's disease characteristics and preferences. Participants are grouped according to the therapy they receive, and no experimental treatments or randomization are involved. Participants will be followed for three years, during which researchers will monitor key health indicators like mean pulmonary artery pressure, pulmonary vascular resistance, cardiac output, and walking distance. They will also assess biomarkers like BNP or NT-proBNP levels and functional status using WHO classification. Additional outcomes include transplantation rates and quality of life changes. Data collection includes routine clinical evaluations and long-term tracking of disease progression and treatment effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
  • Willingness to provide informed consent
  • Mean pulmonary artery pressure (mPAP) of 20 mmHg or higher
  • Pulmonary vascular resistance (PVR) of 3 Wood units or higher
  • Pulmonary arterial wedge pressure (PAWP) of 15 mmHg or less
  • Radiographic evidence of organized thrombi in pulmonary arteries after 3 months of effective anticoagulation
  • Age 14 years or older
Not Eligible

You will not qualify if you...

  • Pulmonary hypertension caused mainly by conditions other than CTEPH
  • Participation in a therapeutic clinical trial involving an unknown drug
  • Withdrawal or lack of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 years

Participants who undergo routine care for chronic thromboembolic pulmonary hypertension (CTEPH) are observed to evaluate diagnosis, treatments, and long-term prognosis.

Regular visits depending on clinical management

Trial Site Locations

Total: 1 location

1

China-Japan Frendship hospital

Beijing, China, 100029

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Research Team

Z

Zhenguo Zhai, Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

The management pattern and outcomes of chronic thromboembolic pulmonary hypertension: rationale and design for a Chinese real-world study.

Shuai Zhang, Yishan Li, Yuanhua Yang...

https://pubmed.ncbi.nlm.nih.gov/38825688