Cardiopulmonary Exercise TestNCT07534384
Automated CPET Interpretation: International Validation Study
An observational study of Cardiopulmonary Exercise Test, run by KU Leuven at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Exercise Test
- How many people
- 600 participants
- Where
- 3 sitesBelgium
- Study dates
- 27 Mar 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred for a CPET in one of the participating centers
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
AZORG
Aalst, 9300
Dimitri Stylemans, 0032 53 72 42 89, dimitri.stylemans@azorg.be
Dimitri Stylemans
- Not yet recruiting
Jessa Ziekenhuis
Hasselt
Iwein Gyselinck, 0032 11 33 55 77, Iwein.Gyselinck@jessazh.be
Iwein Gyselinck
- Recruiting
UZ Leuven
Leuven, 3000
Marieke Wuyts, 016 34 31 59, marieke.wuyts@kuleuven.be
Wim Janssens
About this study
Official title: International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing
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:
Read more
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between baseline and 6 months
Secondary outcomes (5)
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Baseline agreement on the survey between the KOLs and the CPET interpretation algorithm will be assessed. The survey assesses CPET interpretation both without and with access to the automated report. 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. This establishes the initial level of alignment before implementation and allows evaluation of the immediate effect of having access to the report.
Measured: Baseline
Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey
Agreement at 6 months on the survey between the KOLs and the CPET interpretation algorithm will be assessed. Again the survey assesses CPET interpretation both without and with access to the automated report. 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.
Measured: 6 months
Changes in self-reported confidence scores before and after the automated report
Change in self-reported confidence scores before and after using the automated report. Confidence will be rated on a 5-point Likert scale across interpretation domains. Within-timepoint comparisons (without vs. with algorithm) and across-time comparisons (baseline vs. 6 months) will be made.
Measured: At baseline, at 6 months, and the change between baseline and 6 months
Feedback on the automated protocols during the 6-month implementation period
Feedback on automated protocols generated via the platform during the 6-month implementation period. Changes will be categorised as: accept, accept with minor change, accept with major change or reject. This helps to quantify how the automated interpretation is accepted or refined in practice.
Measured: During the 6 months implementation period
Descriptive evaluation of center-level CPET interpretation practices
Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints: at baseline, 3 months and 6 months on a random sample (n=10) of included participants of CPET interpretation reports per center, using structured qualitative coding of report content across interpretation domains to assess potential shifts in reporting style, terminology, and completeness.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start27 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary Exercise TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZORG, Jessa Hospital
- Responsible party
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534384
- Sponsor's protocol ID
- S70961
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing
- ClinicalTrials.gov ID
- NCT07534384
- Acronym / sponsor ID
- S70961
- Conditions
- Cardiopulmonary Exercise Test
- Keywords
- CPET, automated interpretation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- AZORG, Jessa Hospital
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for a CPET in one of the participating centers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Time frame: between baseline and 6 months
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.
5 secondary outcomes
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Time frame: Baseline
Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey
Time frame: 6 months
Changes in self-reported confidence scores before and after the automated report
Time frame: At baseline, at 6 months, and the change between baseline and 6 months
Feedback on the automated protocols during the 6-month implementation period
Time frame: During the 6 months implementation period
Descriptive evaluation of center-level CPET interpretation practices
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wim Janssens principal investigator
UZ/KU Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Exercise Test, run by KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marieke Wuyts (016 34 31 59, marieke.wuyts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey (time frame: between baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.