Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment5000 (estimated)
SponsorProlaio
Industry-sponsored
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedOctober 30, 2025
Main results expectedOctober 2030
Study endsOctober 2030
Registry record updatedAugust 12, 2026
Trial IDNCT07420907 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

  • Prolaio
    Chicago, Illinois, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.