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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.
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- 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 (device)
Sponsor: CHFDX,Inc. · Participants: 60 · Started: Mar 9, 2026
Contact the study team
- Robby Wu, DO · Phone: 813-844-7000
- Rohitha Moudgal, MD · Phone: 813-844-7000
Official record on ClinicalTrials.gov — NCT07350759
Locations in the U.S.
| Florida | USF, Tampa USF Office of Clinical Research, Tampa (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.