Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using FDA-cleared wearable biosensors worn by study participants. This study will aim to collect data using wearable biosensors from standard of care patients toward the development of an algorithm that can estimate peak VO2 (eVO2peak) from biosensor data. In addition, this study will explore to further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing. A total of 2000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 1900 participants.

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Key information

Conditions

Cardiopulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Health Cardiac Rehabilitation, St. John's, Newfoundland and Labrador, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Willing and able to comply with protocol procedures and available for the duration of the study.
Willing to sign and date informed consent document for study participation.
Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care

Exclusion criteria

Participant is pregnant, lactating or ≤30 days post-partum.
Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).

If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded.
Barostim (™) or similar noncardiac electrical pulse generating device in situ.
Complex congenital heart disease (even repaired or palliated) with the following exception:

Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator.
Any history of allergy to adhesive
Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0, or perform a maximal CPET in the judgement of the investigator, and/or any limitations pertaining to obtaining a complete Echo

Treatment and study plan

Primary outcomes

Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm.

Time frame: From enrollment to the end of collection at 7 days

Develop an Estimated Peak VO2 (eVO2peak) algorithm which will estimate a participant's peak VO2 value using data collected from physiological wearable biosensors (ECG & Activity).

Secondary outcomes

Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors

Time frame: From enrollment to the end of collection at 7 days

Further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials at Prolaio

CONTACT

[email protected]

855-869-9054

Sponsors and collaborators

Lead sponsor

Prolaio

Industry

Registry information

Official study title

An Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Jan 10, 2023
Registry last updated: Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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