RecruitingNCT06405126

Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension

Optimizing the Pulmonary Hypertension Diagnostic Network in Belgium: Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension

Sponsor

KU Leuven

Enrollment

100 participants

Start Date

Feb 21, 2024

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension Pulmonary Arterial Hypertension HFpEF - Heart Failure With Preserved Ejection Fraction

Summary

In this study the diagnostic accuracy of a diagnostic tool for the diagnosis of post-capillary pulmonary hypertension will be investigated. The diagnostic tool was designed based on artificial intelligence, using machine learning on a database of 344 patients with group 1 or group 2 pulmonary hypertension. The tool uses 20 non-invasive parameters which are derived from laboratory results, ECG, echocardiography and spirometry. Based on these parameters, the predictive tool estimates the probability of group 2 pulmonary hypertension. During this clinical study, patients with an intermediate or high suspicion of pulmonary hypertension, with an indication for a diagnostic right heart catheterization, will be included. Patients with risk factors for group 3, 4 or 5 pulmonary hypertension will be excluded. The necessary parameters to run the predictive model will be extracted from the patients medical file. Patients will undergo a standard of care right heart catheterization (gold standard). Afterwards the results of the predictive model will be compared to those of the right heart catheterization, to allow the assessment of the sensitivity, specificity, positive and negative predictive value of the predictive tool.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a machine learning model can correctly tell apart two types of pulmonary hypertension (high blood pressure in the lungs) — post-capillary (caused by heart problems) and pre-capillary (caused by lung vessel problems) — using standard, non-invasive tests, to reduce the need for invasive heart catheterization in some patients. **You may be eligible if...** - You are 18 or older - You have undergone standard tests (echocardiogram, lung function tests, ECG, blood tests) - Echocardiogram results suggest intermediate to high probability of pulmonary hypertension - Your doctor recommends a right heart catheterization based on current guidelines **You may NOT be eligible if...** - You have significant lung disease (FEV1 below 60%) or significant abnormal lung tissue on imaging - You have abnormal V/Q scan or CT angiography findings suggesting clot-related pulmonary hypertension - You have conditions linked to certain known types of pulmonary hypertension such as connective tissue disease, HIV, portal hypertension, or congenital heart disease - You have blood disorders or metabolic conditions associated with other types of pulmonary hypertension Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOptiek predictive model

Patient data will be extracted to run the predictive model, which will estimate the probability of group 2 pulmonary hypertension. However the results of the model will have no diagnostic or therapeutic implications in this phase of the investigation.