NCT07534384

Automated CPET Interpretation: International Validation Study

International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational experimental study is to validate a rule-based algorithm to automate CPET interpretation. The endpoints of this study are the following: * The change in agreement between key opinion leaders (KOLs) and the algorithm-generated CPET interpretation reports, comparing baseline to the end of the 6 month study period. * Baseline agreement between KOLs and the algorithm * Agreement at 6 months between KOLs and the algorithm * Change in self-reported confidence scores before and after using the automated report * Feedback on automated protocols generated via the platform during the 6-month implementation period * Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints Patients referred for a CPET will be included to collect observational data without interference within clinical routine. KOLs will be recruited from participating centres to fill out a survey for CPET interpretations.

Conditions

• Cardiopulmonary Exercise Test

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

2 sites across 1 country: Belgium