Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06405126

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

Sponsor: KU Leuven

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-02-21

Completion Date

2026-02

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Optiek 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.

Locations (4)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Jessa Hospital

Hasselt, Limburg, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium