Pulmonary Arterial HypertensionNCPVDNCT05368467
National Registry and Cohort Study of Pulmonary Vascular Disease
An observational study of Pulmonary Arterial Hypertension, run by Nanjing First Hospital, Nanjing Medical University at 13 sites in China.
Trial summary
This is a observational、multicenter, prospective cohort study for patients with pulmonary hypertension (PH). The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with PH；also to set up registration system of PH in China, to build a database of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- The clinical course and disease management
- How many people
- 1,000 participants
- Where
- 13 sitesChina
- Study dates
- 29 Mar 2022to 30 Dec 2028
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Pulmonary Hypertension from China based PH centers.
Who may be able to join
- Newly diagnosed or previously diagnosed patients with PH.
- Documentation of mean pulmonary arterial pressure (mPAP) >20 mm Hg by right heart catheterization, performed at any time prior to study enrollment.
Who cannot join
- Have not had documentation of hemodynamic criteria for PH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PH.
- Do not meet the required hemodynamic criteria for entry into the study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Anzhen Hospital of Capital Medical University
Beijing
Hong Gu
- Recruiting
China-japan Friendship Hospital
Beijing
zhenguo zhai
- Recruiting
Xiangya Second Hospital, Central South University
Changsha
Jiang, Li
- Recruiting
West China Hospital, Sichuan University
Chendu
Yucheng, Chen
- Recruiting
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong
Caojing Zhang
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shaoliang Chen, MD, +86 13605157029, chmengx@126.com
Shaoliang Chen, MD
- Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiaxin Ye
- Recruiting
General Hospital of Northen Theater of Command
Shenyang
Qiguang Wang
- Recruiting
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Zhenweng Yang
- Recruiting
Tongji Hospital, Huazhong University of Science and Technology
Wuhan
Xiaomei Guo
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Gangcheng Zhang
- Recruiting
First Affiliated Hospital of Xi'An Jiaotong University
Xi'an
Fenling Fan
- Recruiting
First Hospital of Zhengzhou University
Zhengzhou
Heping Gu
About this study
This is a observational、multicenter, prospective cohort study for patients with pulmonary hypertension (PH). The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with PH；also to set up registration system of PH in China, to build a database of Chinese PH, to establish a web-based international standard data acquisition system for PH and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of PH.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- The clinical course and disease management
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The clinical course and disease managementCombination product
The clinical course and disease management of pulmonary hypertension patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions. Receives: Combination Product: The clinical course and disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Death
Measured: 5 years
Secondary outcomes (1)
Number of Participants with Clinical Worsening
Clinical worsening during follow-up was defined as worsening PAH or atrial septostomy or listing for lung transplantation or all-cause death. Worsening PAH required the presence of worsening PAH symptoms and a decrease in 6-minute walk distance greater than 15% from baseline and the requirement for additional PAH treatments (all three conditions had to be present).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start29 Mar 2022
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368467
- Sponsor's protocol ID
- NMU20220505
- Acronym
- NCPVD
- Status last verified
- Jun 2025
- First submitted
- 5 May 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry and Cohort Study of Pulmonary Vascular Disease
- ClinicalTrials.gov ID
- NCT05368467
- Acronym / sponsor ID
- NCPVD / NMU20220505
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 May 2022 (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.
This is a observational、multicenter, prospective cohort study for patients with pulmonary hypertension (PH). The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with PH；also to set up registration system of PH in China, to build a database of Chinese PH, to establish a web-based international standard data acquisition system for PH and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of PH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Combination Product: The clinical course and disease managementAll consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Pulmonary Hypertension from China based PH centers.
Key inclusion criteria (2 listed)
- Newly diagnosed or previously diagnosed patients with PH.
- Documentation of mean pulmonary arterial pressure (mPAP) >20 mm Hg by right heart catheterization, performed at any time prior to study enrollment.
Key exclusion criteria (2 listed)
- Have not had documentation of hemodynamic criteria for PH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PH.
- Do not meet the required hemodynamic criteria for entry into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The clinical course and disease managementThe clinical course and disease management of pulmonary hypertension patients | Combination product | 1 |
Primary outcome
All-cause Death
Time frame: 5 years
1 secondary outcome
Number of Participants with Clinical Worsening
Time frame: 5 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 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
13 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 Arterial Hypertension, run by Nanjing First Hospital, Nanjing Medical University at 13 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 2 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 Shao-Liang Chen, MD, PhD (+86-25-52271351, chmengx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.