ClinicalTrials.gg
RecruitingNCT07420907OCOROUpdated Aug 12, 2026

Study of the Progression of Chronic Cardiovascular Conditions

An observational study in Cardiovascular Disease (CVD), Heart Failure and Aortic Stenosis, sponsored by Prolaio. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Prolaio · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • 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
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Prolaio is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age and older
  • Ability to understand study assessments and give 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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Longitudinal Assessment of Clinical Status

    Measured by Heart Rate (beats per minute)

    Time frame: Baseline through each 90-day cycle

  2. Longitudinal Assessment of Clinical Status

    Heart Rate Variability (per millisecond)

    Time frame: Baseline through each 90-day cycle

  3. Longitudinal Assessment of Clinical Status

    percentage of Atrial Fibrillation Burden (duration of time per day of demonstrated AF)

    Time frame: Baseline through each 90-day cycle

  4. Longitudinal Assessment of Clinical Status

    Breaths per minute

    Time frame: Baseline through each 90-day cycle

07

Study locations

1 of 1 sites recruiting
  • Prolaio
    Chicago, Illinois 60606, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07420907
Lead sponsor
Prolaio
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Oct 30, 2025
Primary completion
Oct 2030 (estimated)
Completion
Oct 2030 (estimated)
Last update
Aug 12, 2026

Study contacts

Study Team OCORO Study
Contact
OCOROstudy@prolaio.com
1-855-869-9054

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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