Clinical trial NCT06954727: China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization
Official title: China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Pulmonary Embolism (Diagnosis)
Pulmonary Arterial Hypertension
Right Heart Catheterization
Keywords: right heart catheterization
pulmonary hypertension
pulmonary arterial hypertension
pulmonary vascular disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 10000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-month all cause death
timeFrame: 3 month
Secondary outcomes:
measure: dignosis and type of pulmonary hypertension
timeFrame: 1 month
measure: 1-year all cause death
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Zhenguo Zhai, PhD
role: PRINCIPAL_INVESTIGATOR
References: