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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура pulmonary endarterectomy or balloon pulmonary angioplasty
  A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.

Первичные конечные точки

• death [Срок оценки: 3 years]
• The change in mean pulmonary artery pressure (mPAP) in millimetre of mercury (mmHg), pulmonary vascular resistance (PVR) in Wood units, cardiac output (CO) in liter per minute (L/min) or cardiac index (CI) in liter per minute (L/min). [Срок оценки: 3 years]
• The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter（pg/ml), or WHO-functional class. [Срок оценки: 3 years]

Вторичные конечные точки (2)

• lung or heart and lung transplantation [Срок оценки: 3 years]
• changes of health related quality of life [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Main cause of PH other than CTEPH
• Participation in a therapeutic clinical trial with an unknown drug;
• Withdrawal or lack of informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• China-Japan Frendship hospital — Пекин

Публикации

• Zhang S, Li Y, Yang Y, Gong S, Yang Z, Hong C, Cui X, Wan J, Ji Y, Chen H, Zhu L, Li C, Cheng Z, Zhang Y, Wang Q, Luo Q, Guo L, Ma G, Han B, Liu Z, Xiong C, Wang L, Ji Q, Li F, Wang S, Zhang Z, Zhang Y, Wang D, Gao Q, Huang Q, Xie W, Zhai Z, Wang C. The management pattern and outcomes of chronic thromboembolic pulmonary hypertension: rationale and design for a Chinese real-world study. BMC Pulm Me PMID 38825688

Идентификаторы

NCT: NCT05311072 · Change-CTEPH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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