National Registry and Cohort Study of Pulmonary Vascular Disease (NCPVD)

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 Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Combination product: The clinical course and disease management

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Shao-Liang Chen, MD, PhD; Phone Number: +86-25-52271351; Email: chmengx@126.com
• Study Contact Backup: Name: Jing Kan, MPH; Phone Number: +86-25-52271398; Email: kanjingok@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: zhenguo zhai
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital of Capital Medical University
    • Contact: Hong Gu
  • Changsha, China
    • Recruiting
    • Xiangya Second Hospital, Central South University
    • Contact: Jiang, Li
  • Chendu, China
    • Recruiting
    • West China Hospital, Sichuan University
    • Contact: Yucheng, Chen
  • Nanjing, China
    • Recruiting
    • Nanjing Drum Tower Hospital
    • Contact: Jiaxin Ye
  • Shenyang, China
    • Recruiting
    • General Hospital of Northen Theater of Command
    • Contact: Qiguang Wang
  • Wuhan, China
    • Recruiting
    • Zhongnan Hospital of Wuhan University
    • Contact: Gangcheng Zhang
  • Wuhan, China
    • Recruiting
    • Tongji Hospital, Huazhong University of Science and Technology
    • Contact: Xiaomei Guo
  • Xi'an, China
    • Recruiting
    • First Affiliated Hospital of Xi'an JiaoTong University
    • Contact: Fenling Fan
  • Zhengzhou, China
    • Recruiting
    • First Hospital of Zhengzhou University
    • Contact: Heping Gu
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial Peoples Hospital
      • Contact: Caojing Zhang
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Principal Investigator: Shaoliang Chen, MD
      • Contact: Shaoliang Chen, MD; Phone Number: +86 13605157029; Email: chmengx@126.com
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • General Hospital of Tianjin Medical University
      • Contact: Zhenweng Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Pulmonary Hypertension from China based PH centers.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions.	Combination product: The clinical course and disease management; The clinical course and disease management of pulmonary hypertension patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause Death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 years

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Vascular Diseases
• Other Study ID Numbers: NMU20220505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No