Using a wearable ring to detect worsening heart failure
An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.
This will see if data from a wearable ring can predict worsening heart failure in adults who already have a pulmonary artery pressure monitor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHFDX,Inc. Industry-sponsored |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT07350759 on ClinicalTrials.gov |
What this trial studies
Adults with chronic congestive heart failure who already use a remote pulmonary artery pressure monitor will wear a non-invasive ring device continuously for 6–12 months while continuing standard care. The study will compare time-series wearable signals (heart rate, HRV, oxygen saturation, activity, sleep, temperature and other metrics) with pulmonary artery pressure–defined sentinel events to identify predictive patterns. Machine-learning and statistical models will be trained on the days before and after sentinel events to develop an algorithm for early detection of decompensation. Optional biospecimens and weekly voice recordings will be collected to support future biomarker and digital-phenotype research.
Who should consider this trial
Good fit: Adults (≥18) with chronic congestive heart failure who already use a hemodynamic pulmonary artery pressure monitor, have had at least 4 weeks of stable goal pressures, and own a smartphone with connectivity are ideal candidates.
Not a fit: People without a pulmonary artery pressure monitor, those unlikely to wear the device regularly, pregnant women, or those who cannot consent or read English are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide earlier, noninvasive warnings of heart failure worsening and help prompt treatment changes before hospitalization is needed.
How similar studies have performed: Previous work with implanted pulmonary artery monitors is established and preliminary wearable-sensor studies have shown promise, but using continuous wearable data to predict decompensation remains an emerging approach with limited definitive proof.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida and 1 other locations
- USF Office of Clinical Research — Tampa, Florida, United States (Not_yet_recruiting)
- Usf — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Wu, DO — Tampa General Hospital
- Study coordinator: Robby Wu, DO
- Email: Robbywu@usf.edu
- Phone: 813-844-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.