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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Run Dong, MD
- Telefoonnummer: 861069155036
- E-mail: dongrun5858@foxmail.com
Studie Locaties
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Beijing, China, 100730
- Werving
- Peking Union Medical College Hospital
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Contact:
- Run Dong
- Telefoonnummer: +86 10 69155036
- E-mail: dongrun5858@foxmail.com
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Hoofdonderzoeker:
- Jinmin Peng, MD
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Shanghai, China
- Werving
- Shanghai Pulmonary Hospital
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Contact:
- Wenhui Wu, MD
- Telefoonnummer: +86 21 65115006
- E-mail: wenhui5621006@126.com
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Guangdong
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Guangzhou, Guangdong, China
- Werving
- Guangdong Province People's Hospital
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Contact:
- Xianmei Li, MD
- Telefoonnummer: +86 20 8382 7812
- E-mail: lixianmei@gdph.org.cn
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Yunnan
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Kunming, Yunnan, China
- Werving
- Yan'an Affiliated Hospital of Kunming Medical University
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Contact:
- Hailong Dai, MD
- Telefoonnummer: +86 0871 63211157
- E-mail: dhlkm@qq.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Pulmonary hypertension
Patients with right heart catheter confirmed pulmonary hypertension
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pulmonary hypertension crisis
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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All cause mortality within hospitalization
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jinmin Peng, MD, Peking Union Medical College Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
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Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- K7949
- 2024ZD0526701 (Ander subsidie-/financieringsnummer: Ministry of Science and Technology of the People's Republic of China)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
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