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ClinicalTrials.gov ID

NCT07534384

Lead Sponsor

KU LeuvenOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Apr 16, 2026Actual

Start Date

Mar 30, 2026Estimated

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Nov 30, 2026Estimated

Official Title

International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing

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.

• Cardiopulmonary Exercise Test

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

KU LeuvenOTHER

Collaborators

AZORGUNKNOWN

marieke.wuyts@kuleuven.be016 34 31 59