An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.
CHFDX,Inc.
Summary
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.
Description
Participants with chronic congestive heart failure and using a pulmonary artery pressure monitor will be enrolled and followed for a minimum of 6 months and up to 12 months. Daily pulmonary artery (PA) pressures obtained via the remote monitoring device will serve as the reference standard for identifying decompensated CHF events ("sentinel events"), defined by sustained elevations in PA diastolic pressure associated with medication changes by the clinical care team. Physiologic data from the wearable-including heart rate, heart rate variability, sleep metrics, activity levels, oxygen saturat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • 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 Exclusion Criteria: * • Inability to provide informed consent * Inability to read or understand English * Likely non-adherence to wearable device use * Prisoners * Pregnant females
Interventions
- Devicewearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters
In 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.
Locations (2)
- USF Office of Clinical ResearchTampa, Florida
- USFTampa, Florida