Automated CPET Interpretation: International Validation Study
International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing
- Cardiopulmonary Exercise Test
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- KU Leuven
- Enrolment target
- 600
- Started
- 27 March 2026
- Main results due
- 30 November 2026
- Study sites
- 3
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(3)
AZORG
Aalst, Belgium
Recruiting
Jessa Ziekenhuis
Hasselt, Belgium
Not yet recruiting
UZ Leuven
Leuven, Belgium
Recruiting
Showing 3 of 3 sites. 2 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07534384. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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