NCT07534384 Automated CPET Interpretation: International Validation Study
| NCT ID | NCT07534384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Cardiopulmonary Exercise Test |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-03-27 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Patients referred for a cardiopulmonary exercise test (CPET): Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * At least 18 years of age at the time of signing the Informed Consent Form * Patients referred for a CPET during their standard clinical care Exclusion Criteria: \- If the participant has a disorder making it unable to perform a CPET, they must not proceed to be enrolled in the study and will be documented as a screen failure via applicable log forms in the Investigator Site File.
Contact & Investigator
Wim Janssens
PRINCIPAL INVESTIGATOR
UZ/KU Leuven
Frequently Asked Questions
Who can join the NCT07534384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiopulmonary Exercise Test. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07534384 currently recruiting?
Yes, NCT07534384 is actively recruiting participants. Contact the research team at marieke.wuyts@kuleuven.be for enrollment information.
Where is the NCT07534384 trial being conducted?
This trial is being conducted at Aalst, Belgium, Hasselt, Belgium, Leuven, Belgium.
Who is sponsoring the NCT07534384 clinical trial?
NCT07534384 is sponsored by KU Leuven. The principal investigator is Wim Janssens at UZ/KU Leuven. The trial plans to enroll 600 participants.