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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06405126
Study type Observational
Source KU Leuven
Contact Laura Hardy, MD
Phone +3216338917
Email laura.hardy@uzleuven.be
Status Recruiting
Phase
Start date February 21, 2024
Completion date February 2026

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