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

NCT06954727 | Recruiting DMC

• 2 other identifiers: CHALLENGE-RHC2023YFC2507200
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

right heart catheterization; pulmonary hypertension; pulmonary arterial hypertension; pulmonary vascular disease

Outcome Measures

Primary Outcomes (1)

• 3-month all cause death

  3-month all cause death

  3 month

Secondary Outcomes (2)

• dignosis and type of pulmonary hypertension

  1 month

• 1-year all cause death

  1 year

Study Arms (1)

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

Interventions

No intervention; Observational study OTHER

No intervention; observational study

Patients who underwent right heart catheterization

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Vital data missing
• Did not sign informed consent or did not agree to follow-up

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism; Disease; Pulmonary Arterial Hypertension

Interventions

Observation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Zhenguo Zhai, PhD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenguo Zhai

CONTACT

010-8420-6265; zhaizhenguo2011@126.com

Yu Zhang, MD

CONTACT

+8613120211583; zhangyuccmu2013@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)