Pulmonary HypertensionNCT06979011
Construction of Clinical Diagnostic Model for Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with all types of PH
Who may be able to join
- 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).
Who cannot join
- Pulmonary veno-occlusive disease (PVOD)
- Active or history of malignancy (or Malignant tumors if referring to current cases)
- Hematologic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction of Diagnostic Models for Pulmonary Hypertension Based on Novel Laboratory Indices and Echocardiogram Parameters
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.
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, diagnosis, machine learning, heamodynamic status
- Medical subject headings
- Hypertension, Pulmonary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary hypertension | people with pulmonary hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
the area under ROC curve
Measured: from 1 Jan 2025 to 30 Apr 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2025
- Primary completion25 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979011
- Sponsor's protocol ID
- LY2025-122-B
- Other IDs
- NSFC82270050
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Diagnostic Models for Pulmonary Hypertension Based on Novel Laboratory Indices and Echocardiogram Parameters
- ClinicalTrials.gov ID
- NCT06979011
- Acronym / sponsor ID
- LY2025-122-B
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, diagnosis, machine learning, heamodynamic status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary hypertension | – | –people with pulmonary hypertension |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with all types of PH
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Pulmonary veno-occlusive disease (PVOD)
- Active or history of malignancy (or Malignant tumors if referring to current cases)
- Hematologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUC
Time frame: from 1 Jan 2025 to 30 Apr 2025
the area under ROC curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: from 1 Jan 2025 to 30 Apr 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.