Study of the Progression of Chronic Cardiovascular Conditions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProlaio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: Cardiovascular Disease (CVD)

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.