China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization (CHA-RHC)

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension; Right Heart Catheterization; Pulmonary Embolism (Diagnosis)
• Intervention / Treatment: Other: No intervention; Observational study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Zhenguo Zhai; Phone Number: 010-8420-6265; Email: zhaizhenguo2011@126.com
• Study Contact Backup: Name: Yu Zhang, MD; Phone Number: +8613120211583; Email: zhangyuccmu2013@yeah.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Zhenguo Zhai; Phone Number: 010-8420-6265; Email: zhaizhenguo2011@126.com
    • Contact: Yu Zhang, MD; Phone Number: 86-13120211583; Email: zhangyuccmu2013@yeah.net
    • Principal Investigator: Zhenguo Zhai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension and age over 14 years old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; Observational study; No intervention; observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month all cause death	3-month all cause death	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dignosis and type of pulmonary hypertension	dignosis and type of pulmonary hypertension according to latest guidelines	1 month
1-year all cause death	1-year all cause death	1 year

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Zhenguo Zhai, PhD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pulmonary hypertension; pulmonary arterial hypertension; pulmonary vascular disease; right heart catheterization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Arterial Hypertension; Hypertension; Pulmonary Embolism; Disease; Vascular Diseases; Embolism; Hypertension, Pulmonary
• Other Study ID Numbers: CHALLENGE-RHC; 2023YFC2507200 (Other Grant/Funding Number: The National Key Research and Development Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We retain the property rights to the patient-level data, and therefore will not share this data. We plan to publish the study results and provide aggregate data when necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No