Following Heart Conditions Over Time Using Digital Monitoring Devices
Observes how long-term heart and blood pressure conditions change, using digital monitoring devices.
Key facts
- Who runs it
- Prolaio
- Where
- Chicago, United StatesSee the site
- Trial code
- Registry title
- Study of the Progression of Chronic Cardiovascular Conditions
- Status
- Recruiting
- People taking part
- 5,000 people, planned
- Started
- 30 Oct 2025
- Expected to end
- Oct 2030
- Type of study
- Observational
- Record updated
- 12 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in the United States who have a long-term heart or blood vessel condition, such as heart failure or high blood pressure. It follows how the condition changes over time.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- A diagnosed long-term cardiovascular disease, such as heart failure (HF), aortic stenosis (AS), hypertrophic cardiomyopathy (HCM), high blood pressure (HTN) or dilated cardiomyopathy (DCM). Other heart conditions may be added at the investigators' discretion. People with severe disease cannot join.
Main reasons for not taking part
- Allergy to the adhesive used in the biosensor patch
- Life-threatening illness outside the heart, such as cancer being treated now or being considered for an organ transplant
- Hospital stay for a heart problem within 30 days before joining, or NYHA functional class IV
- Self-reported weight of 400 pounds (181 kg) or more
- Does not live in the United States or does not understand English instructions
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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 take part
- 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 in United States
- ProlaioChicago, United StatesContact: Study Team OCORO StudyTaking people
About the trial
What the trial wants to find out
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
The group in the trial
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Following Heart Conditions Over Time Using Digital Monitoring DevicesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 August 2026