National Registry and Cohort Study of Pulmonary Vascular Disease

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Combination Product: The clinical course and disease management

• Registration Number: NCT05368467
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-29
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-30
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	The clinical course and disease management	All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions.

Primary Outcome Measures

Name	Time	Method
All-cause Death	5 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Clinical Worsening	5 years	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).

Trial Locations

Locations (13)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China

Guangdong Provincial Peoples Hospital; 🇨🇳 Guangzhou, Guangdong, China

General Hospital of Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, 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

General Hospital of Northen Theater of Command; 🇨🇳 Shenyang, China

Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, China

First Affiliated Hospital of Xi'An Jiaotong University; 🇨🇳 Xi'an, China

First Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China