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Risk Factor Assessment for Acute Pulmonary Hypertension Crisis

15. juni 2026 opdateret af: Peking Union Medical College Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

5000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina, 100730
        • Peking Union Medical College Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Jinmin Peng, MD
      • Shanghai, Kina
        • Shanghai Pulmonary Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Guangdong Province People's Hospital
        • Kontakt:
    • Yunnan
      • Kunming, Yunnan, Kina
        • Yan'an Affiliated Hospital of Kunming Medical University
        • Kontakt:
          • Hailong Dai, MD
          • Telefonnummer: +86 0871 63211157
          • E-mail: dhlkm@qq.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with pulmonary hypertension confirmed by right heart catheterization

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Pulmonary hypertension
Patients with right heart catheter confirmed pulmonary hypertension

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pulmonary hypertension crisis
Tidsramme: From enrollment to 3 years after enrollment
Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
From enrollment to 3 years after enrollment
28 day mortality attributed to pulmonary hypertension crisis
Tidsramme: From hospitalization to 28 days
Death attributed to pulmonary hypertension crisis within 28 days of hospitalization
From hospitalization to 28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All cause mortality within hospitalization
Tidsramme: From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
All cause death within hospitalization
From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
All cause mortality within 3 years
Tidsramme: From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
All cause death within 3 years from the diagnosis of pulmonary hypertension crisis
From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Efterforskere

  • Ledende efterforsker: Jinmin Peng, MD, Peking Union Medical College Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K7949
  • 2024ZD0526701 (Andet bevillings-/finansieringsnummer: Ministry of Science and Technology of the People's Republic of China)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD that underlie the results reported in our publications will be shared after de-identification, including clinical, hemodynamic, laboratory, and imaging data (tables, figures, and appendices).

IPD-delingstidsramme

Beginning 1 year after publication with no end date

IPD-delingsadgangskriterier

Researchers who submit a methodologically sound proposal will be able to access the de-identified individual participant data and supporting documents. Proposals should be directed to the principal investigator at pjm731@hotmail.com. To gain access, requestors will be required to sign a data access agreement, and data will be shared for the purpose of achieving the aims in the approved proposal.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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