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

September 4, 2026 updated by: Prolaio

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.

Study Overview

Status

Recruiting

Conditions

Cardiopulmonary

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials at Prolaio
Phone Number: 855-869-9054
Email: hello@prolaio.com

Study Locations

Canada
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1N3J5
    - Recruiting
    - Eastern Health Cardiac Rehabilitation
    - Contact:
      
      Clinical Research Coordinator
      
      Phone Number: 709-777-7531
      
      Email: Sarah.Anthony@easternhealth.ca
    - Principal Investigator:
      
      Liam Kelly, PhD
United States
- Arizona
  - Scottsdale, Arizona, United States, 85259
    - Recruiting
    - Mayo Clinic Arizona
    - Principal Investigator:
      
      Courtney Wheatley-Guy, PhD
    - Contact:
      
      Research Technologist
      
      Phone Number: 480-301-6021
      
      Email: mccoy.rebekah@mayo.edu
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - VA Palo Alto Healthcare System
    - Contact:
      
      Clinical Research Coordinator
      
      Phone Number: 64661 650-493-5000
      
      Email: jianfu1981@gmail.com
    - Principal Investigator:
      
      Jonathan Myers, PhD
  - San Francisco, California, United States, 94143
    - Recruiting
    - University of California San Francisco
    - Principal Investigator:
      
      Theodore Abraham, MD
    - Contact:
      
      Clinical Research Coordinator
      
      Phone Number: 415-476-2060
      
      Email: Emma.Reagan@ucsf.edu
  - Torrance, California, United States, 90502
    - Recruiting
    - The Lundquist Institute
    - Principal Investigator:
      
      William Stringer, MD
    - Contact:
      
      Program Manager
      
      Phone Number: 310-222-2425
      
      Email: santos.bermejo@lundquist.org
    - Contact:
      
      Study Coordinator
      
      Email: ruchi.pavaskar@lundquist.org
- Delaware
  - Wilmington, Delaware, United States, 19803
    - Recruiting
    - Nemours Cardiac Center
    - Contact:
      
      Research Program Manager
      
      Phone Number: 302-521-8311
      
      Email: carol.prospero@nemours.org
    - Principal Investigator:
      
      Takeshi Tsuda, MD
- Florida
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Memorial Healthcare System, Office of Human Research
    - Contact:
      
      Clinical Research Coordinator
      
      Phone Number: 954-265-1849
      
      Email: PamShaw@mhs.net
    - Principal Investigator:
      
      Iani Patsias, MD
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Florida
    - Principal Investigator:
      
      Bryan J. Taylor, PhD
    - Contact:
      
      Clinical Research Coordinator
      
      Phone Number: (513) 313-7710
      
      Email: carlisle.ashley@mayo.edu
  - Naples, Florida, United States, 34116
    - Completed
    - New Generation Of Medical Research
- Illinois
  - Chicago, Illinois, United States, 60606
    - Completed
    - physIQ
  - Chicago, Illinois, United States, 60608
    - Completed
    - University of Illinois Hospital & Health Sciences System
  - Oakbrook Terrace, Illinois, United States, 60181
    - Completed
    - Advocate Aurora Health Institute
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic
    - Principal Investigator:
      
      Thomas P. Olson, PhD
    - Contact:
      
      Associate Clinical Research Coordinator
      
      Phone Number: 507-422-0541
      
      Email: sailors.emily@mayo.edu
- Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Baylor Scott & White Research Institute
    - Principal Investigator:
      
      Mark Millard, MD
    - Contact:
      
      Research Enrollment Analyst
      
      Phone Number: (214) 818-7621
      
      Email: Erin.Lee@bswhealth.org
  - Plano, Texas, United States, 75093
    - Recruiting
    - Baylor Scott & White The Heart Hospital - Plano
    - Contact:
      
      Supervisor Clinical Research
      
      Phone Number: 469-814-3524
      
      Email: shelby.mccoy@bswhealth.org
    - Principal Investigator:
      
      Aasim M. Afzal, MD
- Utah
  - Murray, Utah, United States, 84107
    - Recruiting
    - Intermountain Medical Center
    - Contact:
      
      Project Coordinator, Outpatient Pulmonary Research
      
      Phone Number: 801-507-4800
      
      Email: Stan.Pies@imail.org
    - Principal Investigator:
      
      Matthew J. Hegewald, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of collection at 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of collection at 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolaio

Investigators

Study Director: Greg Kurio, MD, Prolaio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CTP-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.