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/Actively Recruiting
Led by China-Japan Friendship Hospital · Updated on 2024-01-23
1500
Participants Needed
1
Research Sites
148 weeks
Total Duration
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 patients 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
Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Database in China
Z
Zhenguo Zhai, Ph.D.
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China-Japan Friendship Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Shuai Zhang, Yishan Li, Yuanhua Yang...
https://pubmed.ncbi.nlm.nih.gov/38825688/China-Japan Friendship Hospital
Lead Sponsor