NCT07653958

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 7, 2026

Last Update Submit

June 15, 2026

Conditions

Pulmonary HypertensionPulmonary Hypertension Crisis

Keywords

Pulmonary hypertensionPulmonary hypertension crisisDiagnosisRisk factor

Outcome Measures

Primary Outcomes (2)

  • Pulmonary hypertension crisis

    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

    Death attributed to pulmonary hypertension crisis within 28 days of hospitalization

    From hospitalization to 28 days

Secondary Outcomes (2)

  • All cause mortality within hospitalization

    From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years

  • All cause mortality within 3 years

    From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years

Study Arms (1)

Pulmonary hypertension

Patients with right heart catheter confirmed pulmonary hypertension

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pulmonary hypertension confirmed by right heart catheterization

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Guangdong Province People's Hospital

Guangzhou, Guangdong, China

Location

Yan'an Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

Related Publications (4)

  • 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.

    PMID: 37689662BACKGROUND

  • 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.

    PMID: 30635295BACKGROUND

  • 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.

    PMID: 29074534BACKGROUND

  • 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.

    PMID: 40344188BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Hypertension, PulmonaryDisease

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jinmin Peng, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Run Dong, MD

CONTACT

861069155036dongrun5858@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 1 year after publication with no end date
Access Criteria
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.

Locations

CN(4)