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

Prolaio · NCT05678530

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2000
US sites recruiting
11
Study start
June 6, 2019
Record last updated
September 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Mayo Clinic Arizona

    Scottsdale, AZ 85259

    Site contact: Research Technologist · 480-301-6021 · mccoy.rebekah@mayo.edu

  • VA Palo Alto Healthcare System

    Palo Alto, CA 94304

    Site contact: Clinical Research Coordinator · 650-493-5000 · jianfu1981@gmail.com

  • University of California San Francisco

    San Francisco, CA 94143

    Site contact: Clinical Research Coordinator · 415-476-2060 · Emma.Reagan@ucsf.edu

  • The Lundquist Institute

    Torrance, CA 90502

    Site contact: Program Manager · 310-222-2425 · santos.bermejo@lundquist.org

  • Nemours Cardiac Center

    Wilmington, DE 19803

    Site contact: Research Program Manager · 302-521-8311 · carol.prospero@nemours.org

  • Memorial Healthcare System, Office of Human Research

    Hollywood, FL 33021

    Site contact: Clinical Research Coordinator · 954-265-1849 · PamShaw@mhs.net

  • Mayo Clinic Florida

    Jacksonville, FL 32224

    Site contact: Clinical Research Coordinator · (513) 313-7710 · carlisle.ashley@mayo.edu

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Associate Clinical Research Coordinator · 507-422-0541 · sailors.emily@mayo.edu

  • Baylor Scott & White Research Institute

    Dallas, TX 75246

    Site contact: Research Enrollment Analyst · (214) 818-7621 · Erin.Lee@bswhealth.org

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, TX 75093

    Site contact: Supervisor Clinical Research · 469-814-3524 · shelby.mccoy@bswhealth.org

  • Intermountain Medical Center

    Murray, UT 84107

    Site contact: Project Coordinator, Outpatient Pulmonary Research · 801-507-4800 · Stan.Pies@imail.org

Study contacts (from the official record)

  • Clinical Trials at Prolaio · 855-869-9054 · hello@prolaio.com
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Observational, Non-Interventional Study Supporting Validation of… (NCT05678530) | Bored Studies