Monitoring progression of chronic cardiovascular conditions
Official title: A Non-interventional Observational Study of the Sustained Use of Prolaio Digital Health Devices to Monitor the Natural History of Chronic Cardiovascular Conditions in Ambulatory Patients
Run by Prolaio · NCT07420907 · Data updated 2026-11-12
This project will collect wearable physiologic data from adults with cardiovascular conditions to see how their heart disease changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Prolaio Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 30, 2025 |
| Main results expected | October 2030 |
| Study ends | October 2030 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07420907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) living in the United States with a diagnosed cardiovascular condition such as heart failure, aortic stenosis, hypertrophic or dilated cardiomyopathy, or hypertension who can give informed consent, speak English, and comply with wearing biosensor devices are ideal candidates.
✕Probably not a fit
Patients with recent hospital admission for a cardiac diagnosis within 30 days, NYHA functional class IV, life‑threatening noncardiac illnesses, allergy to the biosensor adhesive, or a self‑reported weight of 400 pounds or greater are unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, longitudinal project that collects physiologic data from adults with a range of cardiovascular conditions to document their natural history. Data collection uses wearable biosensor patches and scheduled data uploads, with participants required to understand consent and follow study instructions in English. People with recent severe cardiac events, end‑stage noncardiac illnesses, or allergy to the patch adhesive are excluded. The study is sponsored by Prolaio and enrolls participants who reside in the United States.
Why it matters
Potential benefit: If successful, the study could improve understanding of how cardiovascular conditions change over time and help guide better monitoring and future treatments.
How similar studies have gone: Previous observational studies using wearable biosensors in cardiovascular populations have generated useful physiological datasets and insights, though they have not yet directly changed standard clinical care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age and older * Ability to understand study assessments and give informed consent to data collection * Ability to comply with the study protocol * Ability to understand and respond to instructions in English * Has diagnosis of qualifying Cardiovascular Disease(s), including but not limited to: HF, AS, HCM, HTN, DCM, etc. Additional CVD may be included at discretion of the investigators. * Resides in the United States Exclusion Criteria: * Allergy to adhesive used in biosensor patch * Life-threatening disease process outside of area under study, such as actively treated cancer or being actively considered for organ pre-transplant (such as hepatic failure; end-stage renal disease). * Severe CVD defined by hospital admission for cardiac diagnosis within 30 days of enrollment or documentation of NYHA functional class IV * \-- For participants who do not qualify due to this exclusion, and have not been hospitalized within 30 days of enrollment, they may reapply to enroll in the study * Self-reported weight of 400 pounds or greater
Where it's running
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Prolaio
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Study Team OCORO Study
- Email: OCOROstudy@prolaio.com
- Phone: 1-855-869-9054
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.