NCPVD: National Registry and Cohort Study of Pulmonary Vascular Disease

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05368467
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 13
• Anticipated Duration (Months): 74.1
• Patients Per Site: 76.9
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Combination Product: The clinical course and disease management

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: National Registry and Cohort Study of Pulmonary Vascular Disease
• Actual Study Start Date: Mar 29, 2022
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: May 30, 2028

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. All-cause Death [5 years]

Secondary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong	China
2	Nanjing First Hospital	Nanjing	Jiangsu	China	210006
3	General Hospital of Tianjin Medical University	Tianjin	Tianjin	China
4	Beijing Anzhen Hospital of Capital Medical University	Beijing		China
5	China-japan Friendship Hospital	Beijing		China
6	Xiangya Second Hospital, Central South University	Changsha		China
7	West China Hospital, Sichuan University	Chendu		China
8	Nanjing Drum Tower Hospital	Nanjing		China
9	General Hospital of Northen Theater of Command	Shenyang		China
10	Tongji Hospital, Huazhong University of Science and Technology	Wuhan		China
11	Zhongnan Hospital of Wuhan University	Wuhan		China
12	First Affiliated Hospital of Xi'An Jiaotong University	Xi'an		China
13	First Hospital of Zhengzhou University	Zhengzhou		China

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaoliang Chen, MD, Vice President of Nanjing First Hospital, Director of Cardiovascular Department, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05368467
• Other Study ID Numbers: NMU20220505
• First Posted: May 10, 2022
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Vascular Diseases

Study Results

No Results Posted as of May 17, 2022