Monitoring progression of chronic cardiovascular conditions
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
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Prolaio Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07420907 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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) (CVD) including but not limited to: HF, AS, HCM, HTN, DCM, etc. * 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 pre/post-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 * Self-reported weight of 400 pounds or greater
Where this trial is running
Chicago, Illinois
- Prolaio — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Study Team OCORO Study
- Email: OCOROstudy@prolaio.com
- Phone: 1-855-869-9054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.