Risk Factor Assessment for Acute Pulmonary Hypertension Crisis
Research on the Clinical Risk Factor Assessment System for Acute Pulmonary Hypertension Crisis and Its Mortality
The goal of this observational study is to learn about pulmonary hypertension crisis (PHC) - a severe, and often fatal complication - in patients with pulmonary hypertension (PH). The main questions this study aims to answer are:
What are the clinical and hemodynamic features of PHC, and what underlying pathophysiological mechanisms cause it to develop? Can these features be used to diagnostic PHC, predict who is at risk of developing it or dying from it, and develop targeted prevention and treatment of PHC?
A multi-center registry platform and biobank will be established to enroll and follow up patients with PH. Clinical data, hemodynamic measurements, and biological specimen will be collected. Risk prediction and early warning tools of PHC will be developed.
研究概览
地位
详细说明
Pulmonary hypertension crisis (PHC) is a severe and fatal complication of pulmonary hypertension (PH), characterized by the sudden elevation of pulmonary vascular resistance, acute right hear failure and collapse of systemic circulation. However, PHC currently lacks any internationally accepted definition or diagnostic criteria, and it is still unclear which are the clinical, pathophysiological and molecular risk factors of PHC.
This study aims to establish a large clinical cohort of patients with PH, validate the definition of PHC, identify risk factors of PHC occurrence and mortality, and develop tools for the risk-prediction and early-warning of PHC.
This is a multi-center, prospective cohort study with a retrospective component for model training. Following national health-information standards, a standardized registry dataset will be established to cover demographics, clinical features, laboratory tests, imaging, and hemodynamic profile. Existing PH cohort databases will be integrated and expanded to a target of 5,000 patients. A subset of cases with right heart catheter parameters (RHC) will be extracted. A multi-center biospecimen management platform will be established.
For PHC onset, the investigators will assemble a clinical-molecular-imaging feature set and use convolutional neural networks and tree-based algorithms for feature extraction, then build a cross-modal prediction model using multi-task learning, neural networks, and a Transformer architecture. The model will be prospectively validated and tuned against real-world performance. For PHC mortality, models will be built on patients meeting the new PHC criteria, using 28-day attributable death, all-cause death, and long-term death as endpoints. Models will be trained on a retrospective cohort and then evaluated for accuracy and generalizability on both an internal validation set and an external prospective-cohort validation set.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Run Dong, MD
- 电话号码：861069155036
- 邮箱：dongrun5858@foxmail.com
学习地点
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Beijing、中国、100730
- 招聘中
- Peking Union Medical College Hospital
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接触：
- Run Dong
- 电话号码：+86 10 69155036
- 邮箱：dongrun5858@foxmail.com
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首席研究员：
- Jinmin Peng, MD
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Shanghai、中国
- 招聘中
- Shanghai Pulmonary Hospital
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接触：
- Wenhui Wu, MD
- 电话号码：+86 21 65115006
- 邮箱：wenhui5621006@126.com
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Guangdong
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Guangzhou、Guangdong、中国
- 招聘中
- Guangdong Province People's Hospital
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接触：
- Xianmei Li, MD
- 电话号码：+86 20 8382 7812
- 邮箱：lixianmei@gdph.org.cn
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Yunnan
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Kunming、Yunnan、中国
- 招聘中
- Yan'an Affiliated Hospital of Kunming Medical University
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接触：
- Hailong Dai, MD
- 电话号码：+86 0871 63211157
- 邮箱：dhlkm@qq.com
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Pulmonary hypertension confirmed by mean pulmonary arterial pressure (mPAP) over 20 mmHg measured by right heart catheter
- At least once per year of follow-up data collection record
Exclusion Criteria:
- Patients with missing baseline or follow-up data
- Complicated by other diseases with significant influence on survival, such as acute coronary syndrome, malignancy, etc.
- Complicated by other diseases with significant influence on hemodynamics, such as sepsis, acute left heart failure, and acute pulmonary embolism, etc.
- Receiving medications with significant influence on hemodynamics
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Pulmonary hypertension
Patients with right heart catheter confirmed pulmonary hypertension
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pulmonary hypertension crisis
大体时间：From enrollment to 3 years after enrollment
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Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
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From enrollment to 3 years after enrollment
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28 day mortality attributed to pulmonary hypertension crisis
大体时间：From hospitalization to 28 days
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Death attributed to pulmonary hypertension crisis within 28 days of hospitalization
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From hospitalization to 28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
All cause mortality within hospitalization
大体时间：From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
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All cause death within hospitalization
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From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
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All cause mortality within 3 years
大体时间：From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
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All cause death within 3 years from the diagnosis of pulmonary hypertension crisis
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From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
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合作者和调查者
调查人员
- 首席研究员：Jinmin Peng, MD、Peking Union Medical College Hospital
出版物和有用的链接
一般刊物
- Qian J, Li M, Zhang X, Wang Q, Zhao J, Tian Z, Wei W, Zuo X, Zhang M, Zhu P, Ye S, Zhang W, Zheng Y, Qi W, Li Y, Zhang Z, Ding F, Gu J, Liu Y, Wang Y, Zeng X; following investigators were collaborators in the CSTAR-PAH study:. Long-term prognosis of patients with systemic lupus erythematosus-associated pulmonary arterial hypertension: CSTAR-PAH cohort study. Eur Respir J. 2019 Feb 14;53(2):1800081. doi: 10.1183/13993003.00081-2018. Print 2019 Feb.
- Hemnes AR, Beck GJ, Newman JH, Abidov A, Aldred MA, Barnard J, Berman Rosenzweig E, Borlaug BA, Chung WK, Comhair SAA, Erzurum SC, Frantz RP, Gray MP, Grunig G, Hassoun PM, Hill NS, Horn EM, Hu B, Lempel JK, Maron BA, Mathai SC, Olman MA, Rischard FP, Systrom DM, Tang WHW, Waxman AB, Xiao L, Yuan JX, Leopold JA; PVDOMICS Study Group. PVDOMICS: A Multi-Center Study to Improve Understanding of Pulmonary Vascular Disease Through Phenomics. Circ Res. 2017 Oct 27;121(10):1136-1139. doi: 10.1161/CIRCRESAHA.117.311737.
- Qu J, Li M, Zhang X, Zhang M, Zuo X, Zhu P, Ye S, Zhang W, Zheng Y, Qi W, Li Y, Zhang Z, Ding F, Gu J, Liu Y, Qian J, Huang C, Zhao J, Wang Q, Liu Y, Tian Z, Wang Y, Wei W, Zeng X. A prognostic model for systemic lupus erythematosus-associated pulmonary arterial hypertension: CSTAR-PAH cohort study. Respir Res. 2023 Sep 9;24(1):220. doi: 10.1186/s12931-023-02522-2.
- Boucly A, Song S, Keles M, Wang D, Howard LS, Humbert M, Sitbon O, Lawrie A, Thompson AAR, Frank P, Kivimaki M, Rhodes CJ, Wilkins MR. Clustering Patients with Pulmonary Hypertension Using the Plasma Proteome. Am J Respir Crit Care Med. 2025 Aug;211(8):1492-1503. doi: 10.1164/rccm.202408-1574OC.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- K7949
- 2024ZD0526701 (其他赠款/资助编号：Ministry of Science and Technology of the People's Republic of China)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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