Clinical trial
National Registry and Cohort Study of Pulmonary Vascular Disease
Name
NMU20220505
Description
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.
Trial arms
Trial start
2022-03-29
Estimated PCD
2024-05-30
Trial end
2028-05-30
Status
Recruiting
Treatment
The clinical course and disease management
The clinical course and disease management of pulmonary hypertension patients
Arms:
1
Size
1000
Primary endpoint
All-cause Death
5 years
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '5 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2024-02-20
1 organization
1 product
1 indication
Organization
Nanjing First HospitalIndication
Pulmonary Arterial Hypertension