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

NCT05678530 | Recruiting

• 1 other identifier: CTP-020
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 16

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  From enrollment to the end of collection at 7 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolaio: lead

Study Sites (16)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

VA Palo Alto Healthcare System

Palo Alto, California, 94304, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

The Lundquist Institute

Torrance, California, 90502, United States

RECRUITING

Nemours Cardiac Center

Wilmington, Delaware, 19803, United States

RECRUITING

Memorial Healthcare System, Office of Human Research

Hollywood, Florida, 33021, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

New Generation of Medical Research

Naples, Florida, 34116, United States

COMPLETED

physIQ

Chicago, Illinois, 60606, United States

COMPLETED

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60608, United States

COMPLETED

Advocate Aurora Health Institute

Oakbrook Terrace, Illinois, 60181, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

RECRUITING

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Eastern Health Cardiac Rehabilitation

St. John's, Newfoundland and Labrador, A1N3J5, Canada

RECRUITING

Study Officials

• Greg Kurio, MD

  Prolaio, Inc

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials at Prolaio

CONTACT

855-869-9054; hello@prolaio.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 10, 2023
• Study Start: June 6, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); CA (1)