Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.
CHFDX,Inc.
60 participants
Mar 9, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- • 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 Criteria5
- • Inability to provide informed consent
- Inability to read or understand English
- Likely non-adherence to wearable device use
- Prisoners
- Pregnant females
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07350759