Study of the Progression of Chronic Cardiovascular Conditions

NCT07420907 | Recruiting

• 1 other identifier: CTP-030
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolaio: lead

Study Sites (1)

Prolaio

Chicago, Illinois, 60606, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Aortic Valve Stenosis; Hypertension; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; familial dilated cardiomyopathy

Condition Hierarchy (Ancestors)

Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Vascular Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Team OCORO Study

CONTACT

1-855-869-9054; OCOROstudy@prolaio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 19, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)