Construction of Clinical Diagnostic Model for Pulmonary Hypertension

Construction of Diagnostic Models for Pulmonary Hypertension Based on Novel Laboratory Indices and Echocardiogram Parameters

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06979011

Enrollment

199

Registered

2025-05-18

Start date

2025-01-01

Completion date

2025-04-30

Last updated

2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension, diagnosis, machine learning, heamodynamic status

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUC	from 1 Jan 2025 to 30 Apr 2025	the area under ROC curve

Countries

China

Outcome results