Construction of Clinical Diagnostic Model for Pulmonary Hypertension

Completed

• Conditions: Pulmonary Hypertension

• Registration Number: NCT06979011
• Lead Sponsor: RenJi Hospital

Brief Summary

Primary objective: To establish a non-invasive diagnostic model for pulmonary hypertension based on laboratory indicators and echocardiographic parameters.

Secondary objectives: To investigate the correlations between laboratory test indicators and echocardiographic data, and to develop new parameters based on preliminary analysis to assist in the diagnosis of pulmonary hypertension

Detailed Description

Data collection:

Collect vital signs (age, sex, etc.), clinical laboratory tests (complete blood count, biochemistry, BNP, D-dimer, and related derived parameters), and echocardiographic data from both the control group and pulmonary hypertension (PH) patients.

Obtain hemodynamic data measured via right heart catheterization (RHC) in PH patients.

Model development:

Construct a clinical diagnostic model using laboratory and echocardiographic data.

Fit hemodynamic parameters of PH patients based on their laboratory indicators, then assess the hemodynamic status using the fitted parameters and compare with actual measurements.

Secondary analyses:

Investigate correlations between echocardiographic parameters and laboratory test indicators in PH patients.

Identify core variables to develop novel diagnostic parameters and evaluate their diagnostic performance.

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-11
• Last Update Submitted: 2025-05-11
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Patients diagnosed with any subtype of pulmonary hypertension (PH) confirmed by right heart catheterization (RHC) between 2020 and 2025.

No gender restrictions; age >18 years.

Availability of complete RHC records, transthoracic echocardiography (TTE), and laboratory test results (echocardiography and lab tests must be performed within one month before or after RHC).

Exclusion Criteria

• Pulmonary veno-occlusive disease (PVOD)

Active or history of malignancy (or Malignant tumors if referring to current cases)

Hematologic disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC	from 1 Jan 2025 to 30 Apr 2025	the area under ROC curve

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China