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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

• Male or female patients of at least 18 years old.

• Availability of the results of a basic work-up:

‣ Medical history, demographic information and clinical information (including BMI)

⁃ Laboratory tests including hemoglobin, hematocrit and uric acid

⁃ ECG

⁃ Pulmonary function tests

⁃ Echocardiography

• Intermediate to high probability of PH based on echocardiography according to the 2022 ESC/ERS guidelines (see Figure 2 and Table 2). (1)

• Indication for RHC according to ESC/ERS 2022 guidelines. (1)

Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Jessa Hospital
RECRUITING
Hasselt
AZ Groeninge
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Laura Hardy, MD
laura.hardy@uzleuven.be
+3216338917
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2026-02
Participants
Target number of participants: 100
Sponsors
Leads: KU Leuven
Collaborators: Research Foundation Flanders

This content was sourced from clinicaltrials.gov

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