Pulmonary HypertensionNCT07653958
Risk Factor Assessment for Acute Pulmonary Hypertension Crisis
An observational study of Pulmonary Hypertension and Pulmonary Hypertension Crisis, run by Peking Union Medical College Hospital at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Hypertension Crisis
- How many people
- 5,000 participants
- Where
- 4 sitesChina
- Study dates
- 17 Jun 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with pulmonary hypertension confirmed by right heart catheterization
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Run Dong, +86 10 69155036, dongrun5858@foxmail.com
Jinmin Peng, MD
- Recruiting
Guangdong Province People's Hospital
Guangzhou, Guangdong
Xianmei Li, MD, +86 20 8382 7812, lixianmei@gdph.org.cn
- Recruiting
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Hailong Dai, MD, +86 0871 63211157, dhlkm@qq.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Wenhui Wu, MD, +86 21 65115006, wenhui5621006@126.com
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Pulmonary hypertension, Pulmonary hypertension crisis, Diagnosis, Risk factor
- Medical subject headings
- Hypertension, Pulmonary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary hypertension | Patients with right heart catheter confirmed pulmonary hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary hypertension crisis
Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
Measured: 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
Measured: From hospitalization to 28 days
Secondary outcomes (2)
All cause mortality within hospitalization
All cause death within hospitalization
Measured: From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
All cause mortality within 3 years
All cause death within 3 years from the diagnosis of pulmonary hypertension crisis
Measured: From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start17 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinmin Peng, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653958
- Sponsor's protocol ID
- K7949
- Other IDs
- 2024ZD0526701
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 37689662Qian 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.
PubMed 30635295Hemnes 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.
PubMed 29074534Boucly 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.
PubMed 40344188
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Clinical Risk Factor Assessment System for Acute Pulmonary Hypertension Crisis and Its Mortality
- ClinicalTrials.gov ID
- NCT07653958
- Acronym / sponsor ID
- K7949
- Keywords
- Pulmonary hypertension, Pulmonary hypertension crisis, Diagnosis, Risk factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary hypertension | – | –Patients with right heart catheter confirmed pulmonary hypertension |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary hypertension confirmed by right heart catheterization
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary hypertension crisis
Time frame: From enrollment to 3 years after enrollment
Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
28 day mortality attributed to pulmonary hypertension crisis
Time frame: From hospitalization to 28 days
Death attributed to pulmonary hypertension crisis within 28 days of hospitalization
2 secondary outcomes
All cause mortality within hospitalization
Time frame: From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
All cause mortality within 3 years
Time frame: From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 37689662Qu 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.
- Background: PubMed 30635295Qian 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.
- Background: PubMed 29074534Hemnes 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.
- Background: PubMed 40344188Boucly 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinmin Peng, MD principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Pulmonary Hypertension Crisis, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Run Dong, MD (861069155036, dongrun5858@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary hypertension crisis (time frame: From enrollment to 3 years after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07653958, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.