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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Run Dong, MD
- Numéro de téléphone: 861069155036
- E-mail: dongrun5858@foxmail.com
Lieux d'étude
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Beijing, Chine, 100730
- Recrutement
- Peking Union Medical College Hospital
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Contact:
- Run Dong
- Numéro de téléphone: +86 10 69155036
- E-mail: dongrun5858@foxmail.com
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Chercheur principal:
- Jinmin Peng, MD
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Shanghai, Chine
- Recrutement
- Shanghai Pulmonary Hospital
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Contact:
- Wenhui Wu, MD
- Numéro de téléphone: +86 21 65115006
- E-mail: wenhui5621006@126.com
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Guangdong
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Guangzhou, Guangdong, Chine
- Recrutement
- Guangdong Province People's Hospital
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Contact:
- Xianmei Li, MD
- Numéro de téléphone: +86 20 8382 7812
- E-mail: lixianmei@gdph.org.cn
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Yunnan
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Kunming, Yunnan, Chine
- Recrutement
- Yan'an Affiliated Hospital of Kunming Medical University
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Contact:
- Hailong Dai, MD
- Numéro de téléphone: +86 0871 63211157
- E-mail: dhlkm@qq.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Pulmonary hypertension
Patients with right heart catheter confirmed pulmonary hypertension
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pulmonary hypertension crisis
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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All cause mortality within hospitalization
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jinmin Peng, MD, Peking Union Medical College Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K7949
- 2024ZD0526701 (Autre subvention/numéro de financement: Ministry of Science and Technology of the People's Republic of China)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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