Study of the Progression of Chronic Cardiovascular Conditions (OCORO)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Hypertension; Aortic Stenosis; Dilated Cardiomyopathy; Cardiovascular Disease (CVD); Aortic Stenosis Disease; Dilated Cardiomyopathy, Familial; Hypertension (HTN); Dilated Cardiomyopathy (DCM); Hypertrophic Cardiomyopathy Patients; Hypertrophic Cardiomyopathy, Obstructive; Hypertrophic Cardiomyopathy Without Obstruction

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Study Team OCORO Study; Phone Number: 1-855-869-9054; Email: OCOROstudy@prolaio.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • Recruiting
      • Prolaio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prolaio

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Laminopathies; Vascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiomyopathies; Aortic Stenosis, Subvalvular; Cardiomegaly; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Failure; Hypertension; Aortic Valve Stenosis; Cardiovascular Diseases; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; familial dilated cardiomyopathy
• Other Study ID Numbers: CTP-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No