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Clinical Trials/NCT05368467
NCT05368467
Recruiting
Not Applicable

National Registry and Cohort Study of Pulmonary Vascular Disease

Nanjing First Hospital, Nanjing Medical University13 sites in 1 country1,000 target enrollmentMarch 29, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Nanjing First Hospital, Nanjing Medical University
Enrollment
1000
Locations
13
Primary Endpoint
All-cause Death
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2022
End Date
December 30, 2028
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaoliang Chen, MD

Vice President of Nanjing First Hospital, Director of Cardiovascular Department

Nanjing First Hospital, Nanjing Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

All-cause Death

Time Frame: 5 years

Secondary Outcomes

  • Number of Participants with Clinical Worsening(5 years)

Study Sites (13)

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