Study of the Progression of Chronic Cardiovascular Conditions

NCT07420907 — Recruiting, 5000 participants, Prolaio

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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

Registry	NCT07420907, acronym OCORO
Status	Recruiting
Study type	Observational
Enrollment	5000 (Estimated)
Sponsor	Prolaio (Industry)
Conditions	Cardiovascular Disease (CVD), Heart Failure, Aortic Stenosis, Aortic Stenosis Disease, Hypertension, Hypertension (HTN), Hypertrophic Cardiomyopathy Patients, Hypertrophic Cardiomyopathy Without Obstruction, Hypertrophic Cardiomyopathy, Obstructive, Dilated Cardiomyopathy (DCM), Dilated Cardiomyopathy, Dilated Cardiomyopathy, Familial
Dates	start 2025-10-30, primary completion 2030-10-01 (estimated), completion 2030-10-01 (estimated), first posted 2026-02-19, last updated 2026-08-12
Locations	1 site in United States

-Summary

This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.

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+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

Longitudinal Assessment of Clinical Status [Baseline through each 90-day cycle]: Measured by Heart Rate (beats per minute)
Longitudinal Assessment of Clinical Status [Baseline through each 90-day cycle]: Heart Rate Variability (per millisecond)
Longitudinal Assessment of Clinical Status [Baseline through each 90-day cycle]: percentage of Atrial Fibrillation Burden (duration of time per day of demonstrated AF)
Longitudinal Assessment of Clinical Status [Baseline through each 90-day cycle]: Breaths per minute

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Prolaio	Chicago, Illinois	United States	Recruiting

My Notes

Public

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