Cardiovascular Disease (CVD)OCORONCT07420907
Study of the Progression of Chronic Cardiovascular Conditions
An observational study of Cardiovascular Disease (CVD) and Heart Failure, run by Prolaio at 1 site in United States.
Trial summary
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease (CVD), Heart Failure, Aortic Stenosis
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Oct 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been diagnosed including but not limited to the following Cardiovascular Disease types: Aortic Stenosis, Heart Failure, Hypertension Obstructive Cardiomyopathy, Dilated Cardiomyopathy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prolaio
Chicago, Illinois, 60606
About this study
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
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
- Conditions
- Cardiovascular Disease (CVD), Heart Failure, Aortic Stenosis, Aortic Stenosis Disease, Hypertension, Hypertension (HTN)
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Aortic Valve Stenosis, Hypertension, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, familial dilated cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Disease (CVD) | Participants who have been diagnosed including but not limited to the following Cardiovascular Disease types: Aortic Stenosis, Heart Failure, Hypertension Obstructive Cardiomyopathy, Dilated Cardiomyopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Assessment of Clinical Status
Measured by Heart Rate (beats per minute)
Measured: Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
Heart Rate Variability (per millisecond)
Measured: Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
percentage of Atrial Fibrillation Burden (duration of time per day of demonstrated AF)
Measured: Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
Breaths per minute
Measured: Baseline through each 90-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start30 Oct 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Prolaio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420907
- Sponsor's protocol ID
- CTP-030
- Acronym
- OCORO
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No