Trials / Recruiting
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Pulmonary Hypertension
- Pulmonary Arterial Hypertension
- HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-02-21
- Primary completion
- 2025-08-01
- Completion
- 2026-02-01
- First posted
- 2024-05-08
- Last updated
- 2024-05-08
Locations
4 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT06405126. Inclusion in this directory is not an endorsement.