China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention; Observational study.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension, Pulmonary Embolism (Diagnosis), Pulmonary Arterial Hypertension, Right Heart Catheterization. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization
Overview
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.
Interventions
- Other No intervention; Observational study
No intervention; observational study
Primary outcome measures
- 3-month all cause death [Time frame: 3 month]
Secondary outcome measures (2)
- dignosis and type of pulmonary hypertension [Time frame: 1 month]
- 1-year all cause death [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06954727 · CHALLENGE-RHC · 2023YFC2507200