About this trial
This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable device. Participants with a remote hemodynamic pulmonary artery pressure monitor will wear a wearable device continuously for up to 12 months. Wearable data will be analyzed in relation to the hemodynamic monitor defined sentinel events of heart failure decompensation to identify predictive signal patterns. Optional biospecimen (DNA, blood, urine) and voice sample collection will support future biomarker discovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Age ≥ 18 years
Current use of a hemodynamic sensoring device
At least 4 consecutive weeks of stabilized "goal" pulmonary artery pressures
Access to a personal smartphone with Wi-Fi or cellular connectivity
Disqualifiers
• Inability to provide informed consent
Inability to read or understand English
Likely non-adherence to wearable device use
Prisoners
Trial population
University of South Florida Tampa General Hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters
DeviceIn this observational study, a non-invasive, wearable ring used for continuous passive collection of physiologic data (sleep, activity, heart rate, HRV, temperature) will be used to collect data from all patients in the study. Data are used solely for research and algorithm development and are not used for diagnosis or treatment.
Treatment groups
Trial outcomes
Primary outcomes
Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF
Identification of reproducible changes in wearable physiologic data that occur in the 1-7 days preceding a hemodynamic monitoring device detection of elevated pulmonary artery pressure sustained over 2 days defined as a sentinel event of decompensated CHF.
Sponsors and contacts
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