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Study of the Progression of Chronic Cardiovascular Conditions

NCT07420907 · Prolaio
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
Eligibility 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) (CVD) including but not limited to: HF, AS, HCM, HTN, DCM, etc. * 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 pre/post-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 * Self-reported weight of 400 pounds or greater
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-10-30
Estimated completion: 2030-10
Last updated: 2026-02-19
Primary outcomes
  • Longitudinal Assessment of Clinical Status (Baseline through each 90-day cycle)
  • Longitudinal Assessment of Clinical Status (Baseline through each 90-day cycle)
  • Longitudinal Assessment of Clinical Status (Baseline through each 90-day cycle)
Sponsor
Prolaio · industry
Contacts & investigators
ContactStudy Team OCORO Study · contact · OCOROstudy@prolaio.com · 1-855-869-9054
All locations (1)
ProlaioRecruiting
Chicago, Illinois, United States
Study of the Progression of Chronic Cardiovascular Conditions · TrialPath