Construction of Clinical Diagnostic Model for Pulmonary Hypertension

NCT ID: NCT06979011

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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pulmonary hypertension

people with pulmonary hypertension

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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NSFC82270050

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LY2025-122-B

Identifier Type: -

Identifier Source: org_study_id

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