National Registry and Cohort Study of Pulmonary Vascular Disease

Pulmonary Arterial Hypertension Clinical Trial

— NCPVD  

Official title:

National Registry and Cohort Study of Pulmonary Vascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368467
• Other study ID #: NMU20220505
• Status: Recruiting
• Start date: March 29, 2022
• Est. completion date: May 30, 2028

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shao-Liang Chen, MD, PhD
• Phone: +86-25-52271351
• Email: chmengx[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 30, 2028
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Arterial Hypertension
• Vascular Diseases

Intervention

Combination Product:
• The clinical course and disease management
The clinical course and disease management of pulmonary hypertension patients

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital of Capital Medical University	Beijing
China	China-japan Friendship Hospital	Beijing
China	Xiangya Second Hospital, Central South University	Changsha
China	West China Hospital, Sichuan University	Chendu
China	Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong
China	Nanjing Drum Tower Hospital	Nanjing
China	Nanjing First Hospital	Nanjing	Jiangsu
China	General Hospital of Northen Theater of Command	Shenyang
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan
China	Zhongnan Hospital of Wuhan University	Wuhan
China	First Affiliated Hospital of Xi'An Jiaotong University	Xi'an
China	First Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death		5 years
Secondary	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