NCT05368467

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Mar 2022Dec 2028

Study Start

First participant enrolled

March 29, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

6.8 years

First QC Date

May 5, 2022

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause Death

    5 years

Secondary Outcomes (1)

  • Number of Participants with Clinical Worsening

    5 years

Study Arms (1)

1

All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions.

Combination Product: The clinical course and disease management

Interventions

The clinical course and disease management of pulmonary hypertension patients

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Pulmonary Hypertension from China based PH centers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

RECRUITING

Beijing Anzhen Hospital of Capital Medical University

Beijing, China

RECRUITING

China-japan Friendship Hospital

Beijing, China

RECRUITING

Xiangya Second Hospital, Central South University

Changsha, China

RECRUITING

West China Hospital, Sichuan University

Chendu, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, China

RECRUITING

General Hospital of Northen Theater of Command

Shenyang, China

RECRUITING

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, China

RECRUITING

First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, China

RECRUITING

First Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Central Study Contacts

Shao-Liang Chen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Nanjing First Hospital, Director of Cardiovascular Department

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

March 29, 2022

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations