China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization

NCT ID: NCT06954727

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2030-12-31

Brief Summary

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Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.

Detailed Description

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This study is led by the China-Japan Friendship Hospital and will be conducted across approximately 30 pulmonary hypertension centers in China. It is an observational cohort study without interventional treatment. Eligible participants are patients aged 14 years or older who undergo right heart catheterization due to dyspnea or suspected pulmonary hypertension. After study initiation, investigators at each center will enroll eligible patients and collect baseline data, hemodynamic parameters from right heart catheterization, diagnostic classification of pulmonary hypertension, and treatment plans. Patients will receive routine follow-up at their respective centers, and investigators will gather follow-up data according to the study protocol. All de-identified data will be recorded in an Electronic Data Capture (EDC) system. A dedicated data management team will oversee data management, quality control, and statistical analysis.

Conditions

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Pulmonary Hypertension Pulmonary Embolism (Diagnosis) Pulmonary Arterial Hypertension Right Heart Catheterization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who underwent right heart catheterization

The study population consists of patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension. No intervention.

No intervention; Observational study

Intervention Type OTHER

No intervention; observational study

Interventions

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No intervention; Observational study

No intervention; observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
* Age ≥14 years old

Exclusion Criteria

* Vital data missing
* Did not sign informed consent or did not agree to follow-up
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhenguo Zhai,MD,PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenguo Zhai, PhD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenguo Zhai

Role: CONTACT

010-8420-6265

Yu Zhang, MD

Role: CONTACT

+8613120211583

Facility Contacts

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Zhenguo Zhai

Role: primary

010-8420-6265

Yu Zhang, MD

Role: backup

86-13120211583

Other Identifiers

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2023YFC2507200

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CHALLENGE-RHC

Identifier Type: -

Identifier Source: org_study_id

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