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

NCT06954727 — Recruiting, 10000 participants, China-Japan Friendship Hospital

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

RegistryNCT06954727, acronym CHA-RHC
StatusRecruiting
Study typeObservational
Enrollment10000 (Estimated)
SponsorChina-Japan Friendship Hospital (Other)
ConditionsPulmonary Hypertension, Pulmonary Embolism (Diagnosis), Pulmonary Arterial Hypertension, Right Heart Catheterization
InterventionsNo intervention; Observational study (Other)
Datesstart 2018-01-01, primary completion 2028-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2025-05-02, last updated 2025-05-21
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Hypertension All trials for Pulmonary Embolism (Diagnosis) All trials of No intervention; Observational study

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients who underwent right heart catheterizationOther: No intervention; Observational studyThe 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 (Other): No intervention; observational study

+Outcome measures

Primary outcomes

  • 3-month all cause death [3 month]: 3-month all cause death

Secondary outcomes

  • dignosis and type of pulmonary hypertension [1 month]: dignosis and type of pulmonary hypertension according to latest guidelines
  • 1-year all cause death [1 year]: 1-year all cause death

+Eligibility

Sex: All, ages: 14 Years to any

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

+Locations (1)

FacilityCityCountryStatus
China-Japan Friendship HospitalBeijingChinaRecruiting

+Investigators