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CompletedNCT06979011Updated May 18, 2025

Construction of Clinical Diagnostic Model for Pulmonary Hypertension

An observational study in Pulmonary Hypertension, sponsored by RenJi Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
199
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • pulmonary hypertension
  • diagnosis
  • machine learning
  • heamodynamic status
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 199 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients with all types of PH

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

Exclusion Criteria:

  • Pulmonary veno-occlusive disease (PVOD)

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

Hematologic disorders

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
199 participants (actual)
Patient registry
No

Groups and cohorts

  • pulmonary hypertension

    people with pulmonary hypertension

06

What researchers measure

Primary outcomes

  1. AUC

    the area under ROC curve

    Time frame: from 1 Jan 2025 to 30 Apr 2025

07

Study locations

1 site
  • Renji Hospital
    Shanghai, Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06979011
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
May 18, 2025
Start date
Jan 1, 2025
Primary completion
Mar 25, 2025
Completion
Apr 30, 2025
Last update
May 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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