PH-DyPred: A Multimodal Dynamic Risk Prediction Study in Pulmonary Hypertension
NCT ID: NCT07131241
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-06-27
2029-06-30
Brief Summary
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Detailed Description
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In addition, biospecimens will be collected to support comprehensive multi-omics profiling. Whole blood, serum, plasma, urine, and stool samples will be obtained and processed using standardized protocols. Blood-derived samples will be used for genomic, proteomic, metabolomic, and microRNA analyses; urine specimens will support metabolomic and renal biomarker assays; and stool samples will be used for gut microbiome sequencing. All biospecimens will be stored in a secure biobank and linked with clinical, imaging, and longitudinal follow-up data using de-identified subject codes to enable integrated multimodal analyses and facilitate future exploratory investigations of disease mechanisms and biomarker discovery.
Health economic evaluation, including cost-effectiveness and budget impact analyses, will be conducted using collected data on healthcare resource utilization, direct medical costs, and clinical outcomes to inform future policy and reimbursement decision-making.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Suspected PH by Echocardiography
This study includes a prospective observational cohort of patients with suspected pulmonary hypertension (PH), identified by transthoracic echocardiography (TTE) showing a pulmonary artery systolic pressure (PASP) ≥35 mmHg. No experimental intervention will be applied. Participants will undergo comprehensive data collection, including echocardiography, cardiac magnetic resonance imaging (CMR), electrocardiography (ECG), laboratory testing, and biospecimen sampling (blood, urine, and stool). Follow-up will occur every 6 months for up to 3 years to record clinical outcomes and support the development of a dynamic, multimodal risk prediction model based on artificial intelligence.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pulmonary artery systolic pressure (PASP) ≥35 mmHg as estimated by echocardiography
* Provided written informed consent
Exclusion Criteria
* Malignancy under active treatment
* Severe infection
* Active autoimmune disease
* Major surgery within the past 3 months
* Pregnant or breastfeeding women
* Severe psychiatric disorder impairing ability to comply with the study protocol
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Fujian Medical University
OTHER
Responsible Party
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Dajun Chai
Professor and Chief Physician, Department of Cardiology
Principal Investigators
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Dajun Chai, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Locations
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fauvel C, Gomberg-Maitland M, Benza RL. Risk Stratification in Pulmonary Hypertension: We Need to "GoDeeper"! Chest. 2024 Sep;166(3):420-422. doi: 10.1016/j.chest.2024.05.020. No abstract available.
Lorenzatti D, Motwani M. Cardiovascular magnetic resonance in pulmonary hypertension: Keeping it simple. Prog Cardiovasc Dis. 2025 May-Jun;90:116-118. doi: 10.1016/j.pcad.2025.04.010. Epub 2025 Apr 26. No abstract available.
Kjellstrom B, Lindholm A, Ostenfeld E. Cardiac Magnetic Resonance Imaging in Pulmonary Arterial Hypertension: Ready for Clinical Practice and Guidelines? Curr Heart Fail Rep. 2020 Oct;17(5):181-191. doi: 10.1007/s11897-020-00479-7.
Meyer GMB, Spilimbergo FB, Altmayer S, Pacini GS, Zanon M, Watte G, Marchiori E, Hochhegger B. Multiparametric Magnetic Resonance Imaging in the Assessment of Pulmonary Hypertension: Initial Experience of a One-Stop Study. Lung. 2018 Apr;196(2):165-171. doi: 10.1007/s00408-018-0097-7. Epub 2018 Feb 12.
van de Veerdonk MC, Kind T, Marcus JT, Mauritz GJ, Heymans MW, Bogaard HJ, Boonstra A, Marques KM, Westerhof N, Vonk-Noordegraaf A. Progressive right ventricular dysfunction in patients with pulmonary arterial hypertension responding to therapy. J Am Coll Cardiol. 2011 Dec 6;58(24):2511-9. doi: 10.1016/j.jacc.2011.06.068.
Small M, Perchenet L, Bennett A, Linder J. The diagnostic journey of pulmonary arterial hypertension patients: results from a multinational real-world survey. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666231218886. doi: 10.1177/17534666231218886.
Hameed A, Condliffe R, Swift AJ, Alabed S, Kiely DG, Charalampopoulos A. Assessment of Right Ventricular Function-a State of the Art. Curr Heart Fail Rep. 2023 Jun;20(3):194-207. doi: 10.1007/s11897-023-00600-6. Epub 2023 Jun 5.
Rachedi NS, Tang Y, Tai YY, Zhao J, Chauvet C, Grynblat J, Akoumia KKF, Estephan L, Torrino S, Sbai C, Ait-Mouffok A, Latoche JD, Al Aaraj Y, Brau F, Abelanet S, Clavel S, Zhang Y, Guillermier C, Kumar NVG, Tavakoli S, Mercier O, Risbano MG, Yao ZK, Yang G, Ouerfelli O, Lewis JS, Montani D, Humbert M, Steinhauser ML, Anderson CJ, Oldham WM, Perros F, Bertero T, Chan SY. Dietary intake and glutamine-serine metabolism control pathologic vascular stiffness. Cell Metab. 2024 Jun 4;36(6):1335-1350.e8. doi: 10.1016/j.cmet.2024.04.010. Epub 2024 May 2.
Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.
Zhao W, Huang Z, Diao X, Yang Z, Zhao Z, Xia Y, Zhao Q, Sun Z, Xi Q, Huo Y, Xu O, Geng J, Li X, Duan A, Zhang S, Gao L, Wang Y, Li S, Luo Q, Liu Z. Development and validation of multimodal deep learning algorithms for detecting pulmonary hypertension. NPJ Digit Med. 2025 Apr 10;8(1):198. doi: 10.1038/s41746-025-01593-3.
Rich S, Haworth SG, Hassoun PM, Yacoub MH. Pulmonary hypertension: the unaddressed global health burden. Lancet Respir Med. 2018 Aug;6(8):577-579. doi: 10.1016/S2213-2600(18)30268-6. Epub 2018 Jun 29. No abstract available.
Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.
Study Documents
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Document Type: Individual Participant Data Set
For more information, please contact: [email protected]
View DocumentRelated Links
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Description: Official website of the First Affiliated Hospital of Fujian Medical University, the lead institution responsible for this study. The site includes institutional information, clinical departments, research governance, and contact information.
Other Identifiers
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MRCTA,ECFAH of FMU[2025]716
Identifier Type: -
Identifier Source: org_study_id
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