Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
Recruiting · NCT07350759 · Observational (researchers observe without assigning treatment) · Lead sponsor: CHFDX,Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- USF Office of Clinical Research - Tampa, Florida, United States
- USF - Tampa, Florida, United States