CardiopulmonaryNCT05678530
Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
An observational study of Cardiopulmonary, run by Prolaio at 16 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary
- How many people
- 2,000 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 6 Jun 2019to 31 Dec 2027
- 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: Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States15 sites, 11 recruiting
- Completed
physIQ
Chicago, Illinois, 60606
- Completed
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60608
- Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Research Enrollment Analyst, (214) 818-7621, Erin.Lee@bswhealth.org
Mark Millard, MD
- Recruiting
Memorial Healthcare System, Office of Human Research
Hollywood, Florida, 33021
Clinical Research Coordinator, 954-265-1849, PamShaw@mhs.net
Iani Patsias, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Clinical Research Coordinator, (513) 313-7710, carlisle.ashley@mayo.edu
Bryan J. Taylor, PhD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Project Coordinator, Outpatient Pulmonary Research, 801-507-4800, Stan.Pies@imail.org
Matthew J. Hegewald, MD
- Completed
New Generation of Medical Research
Naples, Florida, 34116
- Completed
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, 60181
- Recruiting
VA Palo Alto Healthcare System
Palo Alto, California, 94304
Clinical Research Coordinator, 650-493-5000 ext. 64661, jianfu1981@gmail.com
Jonathan Myers, PhD
- Recruiting
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
Supervisor Clinical Research, 469-814-3524, shelby.mccoy@bswhealth.org
Aasim M. Afzal, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Associate Clinical Research Coordinator, 507-422-0541, sailors.emily@mayo.edu
Thomas P. Olson, PhD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Clinical Research Coordinator, 415-476-2060, Emma.Reagan@ucsf.edu
Theodore Abraham, MD
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Research Technologist, 480-301-6021, mccoy.rebekah@mayo.edu
Courtney Wheatley-Guy, PhD
- Recruiting
The Lundquist Institute
Torrance, California, 90502
Program Manager, 310-222-2425, santos.bermejo@lundquist.org
Study Coordinator, ruchi.pavaskar@lundquist.org
- Recruiting
Nemours Cardiac Center
Wilmington, Delaware, 19803
Research Program Manager, 302-521-8311, carol.prospero@nemours.org
Takeshi Tsuda, MD
Canada1 site, 1 recruiting
- Recruiting
Eastern Health Cardiac Rehabilitation
St. John's, Newfoundland and Labrador, A1N3J5
Clinical Research Coordinator, 709-777-7531, Sarah.Anthony@easternhealth.ca
Liam Kelly, PhD
About this study
Official title: An 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.
- Conditions
- Cardiopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy Subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care | |
| Standard of Care | Standard of Care subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm.
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).
Measured: From enrollment to the end of collection at 7 days
Secondary outcomes (1)
Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors
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.
Measured: From enrollment to the end of collection at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start6 Jun 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopulmonaryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prolaio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Kurio, MD, Study director, Prolaio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678530
- Sponsor's protocol ID
- CTP-020
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
- ClinicalTrials.gov ID
- NCT05678530
- Acronym / sponsor ID
- CTP-020
- Conditions
- Cardiopulmonary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ProlaioIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy Subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care |
| Standard of Care | – | –Standard of Care subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Participant is pregnant, lactating or ≤30 days post-partum.
- Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).
- Barostim (™) or similar noncardiac electrical pulse generating device in situ.
- Complex congenital heart disease (even repaired or palliated) with the following exception:
- Any history of allergy to adhesive
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
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).
1 secondary outcome
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
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Greg Kurio, MD study director
Prolaio, Inc
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary, run by Prolaio at 16 sites in 2 countries.
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 8 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 9 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 16 sites in United States, Canada. 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 Clinical Trials at Prolaio (855-869-9054, hello@prolaio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.