Automated CPET Interpretation: International Validation Study

NCT07534384 | Not Yet Recruiting

• 1 other identifier: S70961
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiopulmonary Exercise Test

Keywords

CPET; automated interpretation

Outcome Measures

Primary Outcomes (1)

• Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey

  Change in agreement between key KOLs and the algorithm-generated CPET interpretation reports on the survey, comparing baseline (prior to implementation) to the 6-month study period. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs.

  between baseline and 6 months

Secondary Outcomes (5)

• Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey

  Baseline

• Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey

  6 months

• Changes in self-reported confidence scores before and after the automated report

  At baseline, at 6 months, and the change between baseline and 6 months

• Feedback on the automated protocols during the 6-month implementation period

  During the 6 months implementation period

• Descriptive evaluation of center-level CPET interpretation practices

  Baseline, 3 months and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for a CPET in one of the participating centers

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• KU Leuven: lead
• AZORG: collaborator

Study Sites (2)

AZORG

Aalst, 9300, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Wim Janssens

  UZ/KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke Wuyts

CONTACT

016 34 31 59; marieke.wuyts@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 16, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

BE (2)