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
Qualifiers
• 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 design
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